[Federal Register: January 5, 2005 (Volume 70, Number 3)]
[Notices]
[Page 824-913]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr05ja05-85]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 1998N-0046]
Annual Comprehensive List of Guidance Documents at the Food and
Drug Administration
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is publishing its
annual comprehensive list of all guidance documents currently in use at
the agency. This list is being published under FDA's good guidance
practices (GGPs) regulations. It is intended to inform the public of
the existence and availability of all of our current guidance
documents. It also provides information on guidance documents that have
been added or withdrawn in the past year.
DATES: We welcome general comments on this list and on agency guidance
documents at any time.
ADDRESSES: Submit written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
rm. 1061, Rockville, MD 20852. Submit electronic comments to http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/dockets/ecomments.
We have provided information in the
tables in the SUPPLEMENTARY INFORMATION section of this document on
where to obtain a single copy of any of the guidance documents listed.
FOR FURTHER INFORMATION CONTACT: Regarding GGPs: Lisa Helmanis, Office
of Policy (HF-26), Food and Drug Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301-827-3480.
SUPPLEMENTARY INFORMATION:
I. Background
FDA's GGPs were published in the Federal Register of September 19,
2000 (65 FR 56468), and became effective October 19, 2000. GGPs are
intended to ensure involvement of the public in the development of
guidance documents, and to enhance understanding of the availability,
nature, and legal effect of such guidance (Sec. 10.115 (21 CFR
10.115)). In Sec. 10.115(n)(2), FDA stated that it intended to publish
an annual comprehensive list of guidance documents. The list in this
document updates a comprehensive list that published October 24, 2001
(66 FR 53836).
The following comprehensive list identifies all guidances that have
been issued and are in use, and all draft guidances that have been
distributed for comment and not for implementation. Any guidances that
have been withdrawn since the last publication of this comprehensive
list are also identified. These withdrawn guidances include some final
and draft guidances that had been withdrawn prior to the date of
publication of this list, and some that are being withdrawn as of this
date. In accordance with the agency's general policy on guidances, you
may comment on this list and on any FDA guidance document at any time.
Please note that although we have stated that the ``Guidance for
Industry on Qualified Health Claims in Labeling of Conventional Foods
and Dietary Supplements'' (December 2002) has been ``replaced'' by
subsequent guidance, the agency has not abandoned the position in the
2002 guidance regarding reasonable consumer standard.
We have organized the documents by the issuing center or office
within FDA, and have identified the pertinent intended users or
regulatory activities. The dates in the list refer to the date we
issued the guidances or, where applicable, the last date we revised a
document. Because each issuing center or office maintains its own
database, there are slight variations in the way in which they provide
information in the tables in this document.
The following most frequently used Internet sites for agency
guidances are provided for future reference:
Center for Biologics Evaluation and Research (CBER):
http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cber/guidelines.htm Center for Drug Evaluation and Research (CDER): http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cder/guidance/index.htm
Center for Devices and Radiological Health (CDRH): http://
http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cdrh/guidance.html
Center for Food Safety and Applied Nutrition (CFSAN):
http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.cfsan.fda.gov/dms/guidance.html Center for Veterinary Medicine (CVM): http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cvm/guidance/published.htm
Office of Regulatory Affairs (ORA) and Office of the
[[Page 825]]
/http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/opacom/morechoices/industry/guidance.htm
Guidance Documents Issued by CBER
------------------------------------------------------------------------
How to Obtain a Copy
Intended of the Document
Name of Document Date of User or -----------------------
Issuance Regulatory Mailing Internet
Activity Address Address
------------------------------------------------------------------------
Guidelines for June FDA Office of http://
Immunization of Source 1980 regulated Communica www.fda.g
Plasma (Human) Donors industry tion, ov/cber/
With Blood Substances Training, guideline
and s.htm
Manufactu
rers
Assistanc
e (HFM-
40),
Center
for
Biologics
Evaluatio
n and
Research,
Food and
Drug
Administr
ation,
1401
Rockville
Pike,
Rockville
, MD
20852-144
8, 1-800-
835-4709
or 301-
827-1800
------------------------------------------------------------------------
Collection of Human January Ditto (Do) Do. http://
Leukocytes for Further 28, www.fda.g
Manufacturing (Source 1981 ov/cber/
Leukocytes) memo.htm
------------------------------------------------------------------------
Interferon Test July 28, Do. Do. http://
Procedures: Draft Points 1983 www.fda.g
to Consider (PTC) in the ov/cber/
Production and Testing of guideline
Interferon Intended for s.htm
Investigational Use in
Humans
------------------------------------------------------------------------
Deferral of Blood Donors February Do. Do. http://
Who Have Received the 28, www.fda.g
Drug Accutane 1984 ov/cber/
(isotretinoin/Roche; 13- memo.htm
cis-retinoic acid)
------------------------------------------------------------------------
Equivalent Methods for December Do. Do. Do.
Compatibility Testing 14,
1984
------------------------------------------------------------------------
Plasma Derived From December Do. Do. Do.
Therapeutic Plasma 14,
Exchange 1984
------------------------------------------------------------------------
Draft PTC in the April Do. Do. http://
Production and Testing of 10, www.fda.g
New Drugs and Biologicals 1985 ov/cber/
Produced by Recombinant guideline
DNA Technology s.htm
------------------------------------------------------------------------
Reduction of the Maximum June 2, Do. Do. http://
Platelet Storage Period 1986 www.fda.g
to 5 Days in an Approved ov/cber/
Container memo.htm
------------------------------------------------------------------------
To In Vitro Diagnostic December Do. Do. Do.
Reagent Manufacturers: 6, 1986
Guidance on the Labeling
of Human Blood Derived In
Vitro Diagnostic Devices
in Regard to Labeling for
HTLV-III/LAV Antibody
Testing
------------------------------------------------------------------------
Guideline on General May 1987 Do. Do. http://
Principles of Process www.fda.g
Validation ov/cber/
guideline
s/htm
------------------------------------------------------------------------
Deferral of Donors Who November Do. Do. http://
Have Received Human 25, www.fda.g
Pituitary-Derived Growth 1987 ov/cber/
Hormone memo.htm
------------------------------------------------------------------------
Guideline on Validation of December Do. Do. http://
the Limulus Amebocyte 1987 www.fda.g
Lysate Test as an End- ov/cber/
Product Endotoxin Test guideline
for Human and Animal s.htm
Parenteral Drugs,
Biological Products, and
Medical Devices
------------------------------------------------------------------------
Recommendations for the December Do. Do. http://
Management of Donors and 2, 1987 www.fda.g
Units That Are Initially ov/cber/
Reactive for Hepatitis B memo.htm
Surface Antigen (HbsAg)
------------------------------------------------------------------------
Extension of Dating Period December Do. Do. Do.
for Storage of Red Blood 4, 1987
Cells, Frozen
------------------------------------------------------------------------
To Licensed In Vitro December Do. Do. Do.
Diagnostic Manufacturers: 23,
Handling of Human Blood 1987
Source Materials
------------------------------------------------------------------------
Recommendations for April 6, Do. Do. Do.
Implementation of 1988
Computerization in Blood
Establishments
------------------------------------------------------------------------
Control of Unsuitable April 6, Do. Do. Do.
Blood and Blood 1988
Components
------------------------------------------------------------------------
[[Page 826]]
Discontinuance of July 7, Do. Do. Do.
Prelicensing Inspection 1988
for Immunization Using
Licensed Tetanus Toxoid
and Hepatitis B and
Rabies Vaccines
------------------------------------------------------------------------
Physician Substitutes August Do. Do. Do.
15,
1988
------------------------------------------------------------------------
To Licensed Manufacturers August Do. Do. Do.
of Blood Grouping 26,
Reagents: Criteria for 1988
Exemption of Lot Release
------------------------------------------------------------------------
Revised Guideline for the October Do. Do. Do.
Collection of Platelets, 7, 1988
Pheresis
------------------------------------------------------------------------
To Manufacturers of HTLV-I October Do. Do. Do.
Antibody Test Kits: 18,
Antibody to Human T-Cell 1988
Lymphotropic Virus, Type
I (HTLV-I) Release Panel
I
------------------------------------------------------------------------
HTLV-1 Antibody Testing November Do. Do. Do.
29,
1988
------------------------------------------------------------------------
Use of Recombigen HIV-1 LA February Do. Do. Do.
Test 1, 1989
------------------------------------------------------------------------
Guidance for Autologous March Do. Do. Do.
Blood and Blood 15,
Components 1989
------------------------------------------------------------------------
Use of Recombigen HIV-1 August Do. Do. Do.
Latex Agglutination (LA) 1, 1989
Test
------------------------------------------------------------------------
Draft PTC in the August Do. Do. http://
Manufacture and Clinical 8, 1989 www.fda.g
Evaluation of In Vitro ov/cber/
Tests to Detect guideline
Antibodies to the Human s.htm
Immunodeficiency Virus,
Type 1
------------------------------------------------------------------------
PTC in the Collection, August Do. Do. Do.
Processing, and Testing 22,
of Ex Vivo Activated 1989
Mononuclear Leukocytes
for Administration to
Humans
------------------------------------------------------------------------
Requirements for Septembe Do. Do. http://
Computerization of Blood r 8, www.fda.g
Establishments 1989 ov/cber/
memo.htm
------------------------------------------------------------------------
Abbott Laboratories' HIVAG- October Do. Do. Do.
1 Test for HIV-1 4, 1989
Antigen(s) Not
Recommended for Use as a
Donor Screen
------------------------------------------------------------------------
Guideline for Collection October Do. Do. Do.
of Blood or Blood 26,
Products From Donors With 1989
Positive Tests for
Infectious Disease
Markers (``High Risk''
Donors)
------------------------------------------------------------------------
Guideline for the January Do. Do. http://
Determination of Residual 1990 www.fda.g
Moisture in Dried ov/cber/
Biological Products guideline
s.htm
------------------------------------------------------------------------
Autologous Blood February Do. Do. http://
Collection and Processing 12, www.fda.g
Procedures 1990 ov/cber/
memo.htm
------------------------------------------------------------------------
Use of Genetic Systems HIV- June 21, Do. Do. Do.
2 EIA 1990
------------------------------------------------------------------------
FDA Request for March Do. Do. Do.
Information on Blood 15,
Storage Patterns and Red 1991
Cell Contamination by
Yersinia Enterocolitica
------------------------------------------------------------------------
Revision to October 26, April Do. Do. Do.
1989, Guideline for 17,
Collection of Blood or 1991
Blood Products From
Donors With Positive
Tests for Infectious
Disease Markers (``High
Risk'' Donors)
------------------------------------------------------------------------
Deficiencies Relating to March Do. Do. Do.
the Manufacture of Blood 20,
and Blood Components 1991
------------------------------------------------------------------------
Responsibilities of Blood March Do. Do. Do.
Establishments Related to 20,
Errors and Accidents in 1991
the Manufacture of Blood
and Blood Components
------------------------------------------------------------------------
FDA Recommendations Septembe Do. Do. Do.
Concerning Testing for r 10,
Antibody to Hepatitis B 1991
Core Antigen (Anti-HBc)
------------------------------------------------------------------------
[[Page 827]]
Disposition of Blood Septembe Do. Do. Do.
Products Intended for r 11,
Autologous Use That Test 1991
Repeatedly Reactive for
Anti-HCV
------------------------------------------------------------------------
Clarification of FDA December Do. Do. Do.
Recommendations for Donor 12,
Deferral and Product 1991
Distribution Based on the
Results of Syphilis
Testing
------------------------------------------------------------------------
Supplement to the PTC in April 6, Do. Do. http://
the Production and 1992 www.fda.g
Testing of New Drugs and ov/cber/
Biologics Produced by guideline
Recombinant DNA s.htm
Technology: Nucleic Acid
Characterization and
Genetic Stability
------------------------------------------------------------------------
Revised Recommendations April Do. Do. http://
for the Prevention of 23, www.fda.g
Human Immunodeficiency 1992 ov/cber/
Virus (HIV) Transmission memo.htm
by Blood and Blood
Products
------------------------------------------------------------------------
Use of Fluorognost HIV-1 April Do. Do. Do.
Immunofluorescent Assay 23,
(IFA) 1992
------------------------------------------------------------------------
Revised Recommendations April Do. Do. Do.
for Testing Whole Blood, 23,
Blood Components, Source 1992
Plasma, and Source
Leukocytes for Antibody
to Hepatitis C Virus
Encoded Antigen (Anti-
HCV)
------------------------------------------------------------------------
Exemptions to Permit April Do. Do. Do.
Persons With a History of 23,
Viral Hepatitis Before 1992
the Age of Eleven Years
to Serve as Donors of
Whole Blood and Plasma:
Alternative Procedures,
21 CFR 640.120
------------------------------------------------------------------------
Changes in Equipment for July 21, Do. Do. Do.
Processing Blood Donor 1992
Samples
------------------------------------------------------------------------
Nomenclature for Septembe Do. Do. Do.
Monoclonal Blood Grouping r 28,
Reagents 1992
------------------------------------------------------------------------
Volume Limits for November Do. Do. Do.
Automated Collection of 4, 1992
Source Plasma
------------------------------------------------------------------------
FDA's Policy Statement November Do. Do. http://
Concerning Cooperative 25, www.fda.g
Manufacturing 1992 ov/cber/
Arrangements for Licensed guideline
Biologics s.htm
------------------------------------------------------------------------
Revision of October 7, December Do. Do. http://
1988, Memo Concerning Red 16, www.fda.g
Blood Cell Immunization 1992 ov/cber/
Programs memo.htm
------------------------------------------------------------------------
Draft PTC in the July 12, Do. Do. http://
Characterization of Cell 1993 www.fda.g
Lines Used to Produce ov/cber/
Biologicals guideline
s.htm
------------------------------------------------------------------------
Guidance on Alternatives July 20, Do. Do. Do.
to Lot Release for 1993
Licensed Biological
Products
------------------------------------------------------------------------
Recommendations Regarding July 22, Do. Do. http://
License Amendments and 1993 www.fda.g
Procedures for Gamma ov/cber/
Irradiation of Blood memo.htm
Products
------------------------------------------------------------------------
Deferral of Blood and July 28, Do. Do. Do.
Plasma Donors Based on 1993
Medications
------------------------------------------------------------------------
Revised Recommendations August Do. Do. Do.
for Testing Whole Blood, 5, 1993
Blood Components, Source
Plasma, and Source
Leukocytes for Antibody
to Hepatitis C Virus
Encoded Antigen (Anti-
HCV)
------------------------------------------------------------------------
Clarification of the Use August Do. Do. Do.
of Unlicensed Anti-HCV 19,
Supplemental Test Results 1993
in Regard to Donor
Notification
------------------------------------------------------------------------
Draft Guideline for the Septembe Do. Do. http://
Validation of Blood r 28, www.fda.g
Establishment Computer 1993 ov/cber/
Systems guideline
s.htm
------------------------------------------------------------------------
Guidance Regarding Post December Do. Do. http://
Donation Information 10, www.fda.g
Reports 1993 ov/cber/
memo.htm
------------------------------------------------------------------------
[[Page 828]]
Donor Suitability Related December Do. Do. Do.
to Laboratory Testing for 22,
Viral Hepatitis and a 1993
History of Viral
Hepatitis
------------------------------------------------------------------------
Recommendations for the January Do. Do. Do.
Invalidation of Test 3, 1994
Results When Using
Licensed Viral Marker
Assays to Screen Donors
------------------------------------------------------------------------
Recommendations for July 26, Do. Do. Do.
Deferral of Donors for 1994
Malaria Risk
------------------------------------------------------------------------
Office of Establishment August Do. Do. http://
Licensing and Product 1994 www.fda.g
Surveillance (OELPS), ov/cber/
Advertising and guideline
Promotional Labeling s.htm
Staff, Procedural
Guidance Document (Draft)
------------------------------------------------------------------------
Guidance for Industry for November Do. Do. Do.
the Submission of 1994
Chemistry, Manufacturing,
and Controls Information
for Synthetic Peptide
Substances
------------------------------------------------------------------------
Recommendations to Users December Do. Do. http://
of Medical Devices That 20, www.fda.g
Test for Infectious 1994 ov/cber/
Disease Markers by Enzyme memo.htm
Immunoassay (EIA) Test
Systems
------------------------------------------------------------------------
Timeframe for Licensing February Do. Do. Do.
Irradiated Blood Products 3, 1995
------------------------------------------------------------------------
Revision of August 27, March Do. Do. Do.
1982, FDA Memo: 10,
Requirements for 1995
Infrequent Plasmapheresis
Donors
------------------------------------------------------------------------
To All Licensed March Do. Do. Do.
Establishments Performing 14,
Red Blood Cell 1995
Immunizations: Revised
Recommendations for Red
Blood Cell Immunization
Programs for Source
Plasma Donors
------------------------------------------------------------------------
Recommendations for the June 8, Do. Do. Do.
Deferral of Current and 1995
Recent Inmates of
Correctional Institutions
as Donors of Whole Blood,
Blood Components, Source
Leukocytes, and Source
Plasma
------------------------------------------------------------------------
Guideline for Quality July 11, Do. Do. http://
Assurance in Blood 1995 www.fda.g
Establishments ov/cber/
guideline
s.htm
------------------------------------------------------------------------
FDA Guidance Document July 11, Do. Do. Do.
Concerning Use of Pilot 1995
Manufacturing Facilities
for the Development and
Manufacture of Biological
Products
------------------------------------------------------------------------
Recommendations for August Do. Do. http://
Labeling and Use of Units 8, 1995 www.fda.g
of Whole Blood, Blood ov/cber/
Components, Source memo.htm
Plasma, Recovered Plasma,
or Source Leukocytes
Obtained From Donors With
Elevated Levels of
Alanine Aminotransferase
(ALT)
------------------------------------------------------------------------
Recommendations for Donor August Do. Do. Do.
Screening With a Licensed 8, 1995
Test for HIV-1 Antigen
------------------------------------------------------------------------
PTC in the Manufacture and 1995 Do. Do. http://
Testing of Therapeutic www.fda.g
Products for Human Use ov/cber/
Derived From Transgenic guideline
Animals s.htm
------------------------------------------------------------------------
Draft Reviewers' Guide: October FDA Do. Do.
Informed Consent for 1, 1995 personnel
Plasmapheresis/
Immunization
------------------------------------------------------------------------
Draft Reviewers' Guide: October Do. Do. Do.
Disease Associated 1, 1995
Antibody Collection
Program
------------------------------------------------------------------------
Draft Document Concerning December Do. Do. http://
the Regulation of 1995 www.fda.g
Placental/Umbilical Cord ov/cber/
Blood Stem Cell Products memo.htm
Intended for
Transplantation or
Further Manufacturing
Into Injectable Products
------------------------------------------------------------------------
[[Page 829]]
Donor Deferral Due to Red December FDA Do. Do.
Blood Cell Loss During 4, 1995 regulated
Collection of Source industry
Plasma by Automated
Plasmapheresis
------------------------------------------------------------------------
Draft Document Concerning February Do. Do. Do.
the Regulation of 1996
Peripheral Blood
Hematopoietic Stem Cell
Products Intended for
Transplantation or
Further Manufacturing
Into Injectable Products
------------------------------------------------------------------------
International Conference February Do. Do. http://
on Harmonisation (ICH) 23, www.fda.g
Final Guideline on 1996 ov/cber/
Quality of guideline
Biotechnological s.htm
Products: Analysis of the
Expression Construct in
Cells Used for Production
of r-DNA Derived Protein
Products
------------------------------------------------------------------------
ICH Final Guideline on the March 1, Do. Do. Do.
Need for Long-Term Rodent 1996
Carcinogenicity Studies
of Pharmaceuticals
------------------------------------------------------------------------
Additional Recommendations March Do. Do. http://
for Donor Screening With 14, www.fda.g
a Licensed Test for HIV-1 1996 ov/cber/
Antigen memo.htm
------------------------------------------------------------------------
FDA Guidance Concerning April Do. Do. http://
Demonstration of 1996 www.fda.g
Comparability of Human ov/cber/
Biological Products, guideline
Including Therapeutic s.htm
Biotechnology-Derived
Products
------------------------------------------------------------------------
Additional Recommendations May 16, Do. Do. http://
for Testing Whole Blood, 1996 www.fda.g
Blood Components, Source ov/cber/
Plasma, and Source memo.htm
Leukocytes for Antibody
to Hepatitis C Virus
Encoded Antigen (Anti-
HCV)
------------------------------------------------------------------------
Guidance for Industry--The May 1996 Do. Do. http://
Content and Format for www.fda.g
Pediatric Use Supplements ov/cber/
guideline
s.htm
------------------------------------------------------------------------
Guidance on Applications May 1996 Do. Do. Do.
for Products Comprised of
Living Autologous Cells
Manipulated Ex Vivo and
Intended for Structural
Repair or Reconstruction
------------------------------------------------------------------------
Recommendations and May 29, Do. Do. http://
Licensure Requirements 1996 www.fda.g
for Leukocyte-Reduced ov/cber/
Blood Products memo.htm
------------------------------------------------------------------------
ICH Final Guidelines on July 10, Do. Do. http://
Stablity Testing of 1996 www.fda.g
Biotechnological/ ov/cber/
Biological Products guideline
s.htm
------------------------------------------------------------------------
Recommendations for the July 19, Do. Do. http://
Quarantine and 1996 www.fda.g
Disposition of Units From ov/cber/
Prior Collections From memo.htm
Donors With Repeatedly
Reactive Screening Tests
for Hepatitis B Virus
(HBV), Hepatitis C Virus
(HCV), and Human T-
Lymphotropic Virus Type I
(HTLV-I)
------------------------------------------------------------------------
Guidance for Industry for August Do. Do. http://
the Submission of 1996 www.fda.g
Chemistry, Manufacturing, ov/cber/
and Controls Information guideline
for a Therapeutic s.htm
Recombinant DNA-Derived
Product or a Monoclonal
Antibody Product for In
Vivo Use
------------------------------------------------------------------------
Interim Recommendations December Do. Do. http://
for Deferral of Donors at 11, www.fda.g
Increased Risk for HIV-1 1996 ov/cber/
Group O Infection memo.htm
------------------------------------------------------------------------
PTC on Plasmid DNA December Do. Do. http://
Vaccines for Preventive 1996 www.fda.g
Infectious Disease ov/cber/
Indications guideline
s.htm
------------------------------------------------------------------------
Guidance for the January Do. Do. Do.
Submission of Chemistry, 1997
Manufacturing, and
Controls Information and
Establishment Description
for Autologous Somatic
Cell Therapy Products
------------------------------------------------------------------------
Reviewer Guidance for a January FDA Do. Do.
Premarket Notification 13, personnel
Submission for Blood 1997
Establishment Computer
Software
------------------------------------------------------------------------
[[Page 830]]
PTC in the Manufacture and February FDA Do. Do.
Testing of Monoclonal 28, regulated
Antibody Products for 1997 industry
Human Use
------------------------------------------------------------------------
Proposed Approach to February Do. Do. Do.
Regulation of Cellular 28,
and Tissue-Based Products 1997
------------------------------------------------------------------------
Guidance for Industry for April Do. Do. Do.
the Evaluation of 1997
Combination Vaccines for
Preventable Diseases:
Production, Testing, and
Clinical Studies
------------------------------------------------------------------------
ICH Guidelines for the May 16, Do. Do. Do.
Photostability Testing of 1997
New Drug Substances and
Products
------------------------------------------------------------------------
Guidance for Industry: July Do. Do. Do.
Changes to an Approved 1997
Application: Biological
Products
------------------------------------------------------------------------
Guidance for Industry: July Do. Do. Do.
Changes to an Approved 1997
Application for Specified
Biotechnology and
Specified Synthetic
Biological Products
------------------------------------------------------------------------
Guidance for Industry: July Do. Do. Do.
Screening and Testing of 1997
Donors of Human Tissue
Intended for
Transplantation
------------------------------------------------------------------------
Guidance for Industry: August Do. Do. Do.
Donor Screening for 1997
Antibodies to HTLV-II
------------------------------------------------------------------------
Guidance for Industry: August Do. Do. Do.
Postmarketing Adverse 1997
Experience Reporting for
Human Drug and Licensed
Biological Products:
Clarification of What to
Report
------------------------------------------------------------------------
Guidance for Industry: The Septembe Do. Do. Do.
Sourcing and Processing r 1997
of Gelatin to Reduce the
Potential Risk Posed by
Bovine Spongiform
Encephalopathy (BSE) in
FDA-Regulated Products
for Human Use
------------------------------------------------------------------------
Guidance for FDA and November FDA Do. Do.
Industry: Direct Final 21, personnel
Rule Procedures 1997 and
regulated
industry
------------------------------------------------------------------------
Draft Guidance for December FDA Do. Do.
Industry: Promoting 1997 regulated
Medical Products in a industry
Changing Healthcare
Environment; I. Medical
Product Promotion by
Healthcare Organizations
or Pharmacy Benefits
Management Companies
(PBMs)
------------------------------------------------------------------------
Guidance for Industry: November Do. Do. Do.
Industry-Supported 1997
Scientific and
Educational Activities
------------------------------------------------------------------------
Guidance for Industry: January Do. Do. Do.
Year 2000 Date Change for 1998
Computer Systems and
Software Applications
Used in the Manufacture
of Blood Products
------------------------------------------------------------------------
Draft Guidance for January Do. Do. Do.
Industry: Container and 28,
Closure Integrity Testing 1998
In Lieu of Sterility
Testing as a Component of
the Stability Protocol
for Sterile Products
------------------------------------------------------------------------
Draft Guidance for March Do. Do. Do.
Industry: Manufacturing, 1998
Processing, or Holding
Active Pharmaceutical
Ingredients
------------------------------------------------------------------------
Guidance for Industry: March Do. Do. Do.
Guidance for Human 1998
Somatic Cell Therapy and
Gene Therapy
------------------------------------------------------------------------
Draft Guidance for May 1998 Do. Do. Do.
Industry: Instructions
for Submitting Electronic
Lot Release Protocols to
CBER
------------------------------------------------------------------------
[[Page 831]]
Guidance for Industry: May 14, Do. Do. Do.
Classifying Resubmissions 1998
in Response to Action
Letters
------------------------------------------------------------------------
Guidance for Industry: May 1998 Do. Do. Do.
Pharmacokinetics in
Patients With Impaired
Renal Function--Study
Design, Data Analysis,
and Impact on Dosing and
Labeling
------------------------------------------------------------------------
Guidance for Industry: May 15, Do. Do. Do.
Standards for the Prompt 1998
Review of Efficacy
Supplements, Including
Priority Efficacy
Supplements
------------------------------------------------------------------------
Guidance for Industry: May 1998 Do. Do. Do.
Providing Clinical
Evidence of Effectiveness
for Human Drugs and
Biological Products
------------------------------------------------------------------------
Draft Guidance for June Do. Do. Do.
Industry: Stability 1998
Testing of Drug
Substances and Drug
Products
------------------------------------------------------------------------
Guidance for Industry: June Do. Do. Do.
Errors and Accidents 1998
Regarding Saline Dilution
of Samples Used for Viral
Marker Testing
------------------------------------------------------------------------
ICH Guidance on Ethnic June 10, Do. Do. Do.
Factors in the 1998
Acceptability of Foreign
Clinical Data
------------------------------------------------------------------------
Draft Guidance for June 12, Do. Do. Do.
Industry: Exports and 1998
Imports Under the FDA
Export Reform and
Enhancement Act of 1996
------------------------------------------------------------------------
Guidance for Industry: July Do. Do. Do.
Implementation of Section 1998
126 of the Food and Drug
Administration
Modernization Act of
1997--Elimination of
Certain Labeling
Requirements
------------------------------------------------------------------------
Guidance for Industry: July Do. Do. Do.
Environmental Assessment 1998
of Human Drug and
Biologics Applications
------------------------------------------------------------------------
Draft Guidance for Septembe Do. Do. Do.
Industry: Submitting r 1998
Debarment Certification
Statements
------------------------------------------------------------------------
Guidance for Industry: How Septembe Do. Do. Do.
to Complete the Vaccine r 1998
Adverse Event Reporting
System Form (VAERS-1)
------------------------------------------------------------------------
Guidance for Industry: July Do. Do. Do.
Fast Track Drug 2004
Development Programs--
Designation, Development,
and Application Review
------------------------------------------------------------------------
ICH Guidance on Septembe Do. Do. Do.
Statistical Principles r 16,
for Clinical Trials 1998
------------------------------------------------------------------------
ICH Guidance on Quality of Septembe Do. Do. Do.
Biotechnological/ r 21,
Biological Products: 1998
Derivation and
Characterization of Cell
Substrates Used for
Production of
Biotechnological/
Biological Products
------------------------------------------------------------------------
ICH Guidance on Viral Septembe Do. Do. Do.
Safety Evaluation of r 24,
Biotechnology Products 1998
Derived From Cell Lines
of Human or Animal Origin
------------------------------------------------------------------------
Draft Guidance for November Do. Do. Do.
Industry: General 1998
Considerations for
Pediatric Pharmacokinetic
Studies for Drugs and
Biological Products
------------------------------------------------------------------------
Guidance for Industry: FDA December Do. Do. Do.
Approval of New Cancer 1998
Treatment Uses for
Marketed Drug and
Biological Products
------------------------------------------------------------------------
Draft Guidance for January Do. Do. Do.
Industry: Product Name 1999
Placement, Size, and
Prominence in Advertising
and Promotional Labeling
------------------------------------------------------------------------
[[Page 832]]
Guidance for Industry: January Do. Do. Do.
Content and Format of 1999
Chemistry, Manufacturing,
and Controls Information
and Establishment
Description Information
for a Vaccine or Related
Product
------------------------------------------------------------------------
Guidance on Amended January Do. Do. Do.
Procedures for Advisory 26,
Panel Meetings 1999
------------------------------------------------------------------------
Draft Guidance for October Do. Do. http://
Industry; Providing 2003 www.fda.g
Regulatory Submissions in ov/cber/
Electronic Format-- esub/
General Considerations esubguid.
htm
------------------------------------------------------------------------
Guidance for Industry: February Do. Do. http://
Population 1999 www.fda.g
Pharmacokinetics ov/cber/
guideline
s.htm
------------------------------------------------------------------------
Guidance for Industry: February Do. Do. Do.
Clinical Development 1999
Programs for Drugs,
Devices, and Biological
Products for the
Treatment of Rheumatoid
Arthritis (RA)
------------------------------------------------------------------------
Guidance for Industry: For February Do. Do. Do.
the Submission of 1999
Chemistry, Manufacturing,
and Controls and
Establishment Description
Information for Human
Plasma-Derived Biological
Products, Animal Plasma,
or Serum-Derived Products
------------------------------------------------------------------------
Draft Guidance for March Do. Do. Do.
Industry: Accelerated 1999
Approval Products--
Submission of Promotional
Materials
------------------------------------------------------------------------
Guidance for Industry: March Do. Do. Do.
Content and Format of 1999
Chemistry, Manufacturing,
and Controls Information
and Establishment
Description Information
for a Biological In Vitro
Diagnostic Product
------------------------------------------------------------------------
Guidance for Industry: April Do. Do. Do.
Public Health Issues 1999
Posed by the Use of
Nonhuman Primate
Xenografts in Humans
------------------------------------------------------------------------
Guidance for Industry on April Do. Do. Do.
the Content and Format of 1999
Chemistry, Manufacturing,
and Controls Information
and Establishment
Description Information
for an Allergenic Extract
or Allergen Patch Test
------------------------------------------------------------------------
Guidance for Industry for May 1999 Do. Do. Do.
the Submission of
Chemistry, Manufacturing,
and Controls and
Establishment Description
Information for Human
Blood and Blood
Components Intended for
Transfusion or for
Further Manufacture and
for the Completion of the
Form FDA 356h
``Application to Market a
New Drug, Biologic, or an
Antibiotic Drug for Human
Use''
------------------------------------------------------------------------
Draft Guidance for May 1999 Do. Do. Do.
Industry for Platelet
Testing and Evaluation of
Platelet Substitute
Products
------------------------------------------------------------------------
Guidance for Industry: May 1999 Do. Do. Do.
Efficacy Studies to
Support Marketing of
Fibrin Sealant Products
Manufactured for
Commercial Use
------------------------------------------------------------------------
Draft Reviewer Guidance: June FDA Do. Do.
Evaluation of Human 1999 personnel
Pregnancy Outcome Data
------------------------------------------------------------------------
Draft Guidance for June FDA Do. Do.
Industry: Current Good 1999 regulated
Manufacturing Practice industry
for Blood and Blood
Components: (1)
Quarantine and
Disposition of Prior
Collections From Donors
With Repeatedly Reactive
Screening Tests for
Hepatitis C Virus (HCV);
(2) Supplemental Testing,
and the Notification of
Consignees and
Transfusion Recipients of
Donor Test Results for
Antibody to HCV (Anti-
HCV)
------------------------------------------------------------------------
[[Page 833]]
ICH Guidance on the June 25, Do. Do. Do.
Duration of Chronic 1999
Toxicity Testing in
Animals (Rodent and
Nonrodent Toxicity
Testing)
------------------------------------------------------------------------
Draft Guidance for July Do. Do. Do.
Industry: Clinical 1999
Development Programs for
Drugs, Devices, and
Biological Products
Intended for the
Treatment of
Osteoarthritis (OA)
------------------------------------------------------------------------
Draft Guidance for July Do. Do. Do.
Industry: Interpreting 1999
Sameness of Monoclonal
Antibody Products Under
the Orphan Drug
Regulations
------------------------------------------------------------------------
Draft Guidance for August Do. Do. Do.
Industry: Cooperative 1999
Manufacturing
Arrangements for Licensed
Biologics
------------------------------------------------------------------------
Guidance for Industry: August Do. Do. Do.
Consumer-Directed 1999
Broadcast Advertisements
------------------------------------------------------------------------
Guidance for Industry: August Do. Do. Do.
Possible Dioxin/PCB 1999
Contamination of Drug and
Biological Products
------------------------------------------------------------------------
Guidance for Industry: August Do. Do. Do.
Submission of Abbreviated 1999
Reports and Synopses in
Support of Marketing
Applications
------------------------------------------------------------------------
ICH Guidance on August Do. Do. Do.
Specifications: Test 18,
Procedures and Acceptance 1999
Criteria for
Biotechnological/
Biological Products
------------------------------------------------------------------------
Guidance for Industry: Septembe Do. Do. Do.
Qualifying for Pediatric r 1999
Exclusivity Under Section
505A of the Federal Food,
Drug, and Cosmetic Act
------------------------------------------------------------------------
Guidance for Industry: November Do. Do. Do.
Providing Regulatory 1999
Submissions to CBER in
Electronic Format--
Biologics Marketing
Applications (Biologics
License Application
(BLA), Product License
Application (PLA)/
Establishment License
Application (ELA), and
New Drug Application
(NDA)); revised
------------------------------------------------------------------------
Guidance for Industry: In November Do. Do. Do.
Vivo Drug Metabolism/Drug 1999
Interaction Studies--
Study Design, Data
Analysis, and
Recommendations for
Dosing and Labeling
------------------------------------------------------------------------
ICH of Technical November Do. Do. Do.
Requirements for 8, 1999
Registration of
Pharmaceuticals for Human
Use; M4: Common Technical
Document
------------------------------------------------------------------------
Guidance for Industry: In December Do. Do. Do.
the Manufacture and 1999
Clinical Evaluation of In
Vitro Tests to Detect
Nucleic Acid Sequences of
Human Immunodeficiency
Viruses Types 1 and 2
------------------------------------------------------------------------
Guidance for Reviewers: November FDA Do. Do.
Potency Limits for 2000 personnel
Standardized Dust Mite
and Grass Allergen
Vaccines: A Revised
Protocol
------------------------------------------------------------------------
Guidance for Industry: February FDA Do. Do.
Formal Meetings With 2000 regulated
Sponsors and Applicants industry
for PDUFA Products
------------------------------------------------------------------------
Guidance for Industry: February Do. Do. Do.
Formal Dispute 2000
Resolution: Appeals Above
the Division Level
------------------------------------------------------------------------
Guidance for Industry: February Do. Do. Do.
Gamma Irradiation of 2000
Blood and Blood
Components: A Pilot
Program for Licensing
------------------------------------------------------------------------
[[Page 834]]
Draft Guidance for May 2000 Do. Do. Do.
Industry: Content and
Format of the Adverse
Reactions Section of
Labeling for Human
Prescription Drugs and
Biologics
------------------------------------------------------------------------
Guidance for Industry: June Do. Do. Do.
Recognition and Use of a 2000
Standard for the Uniform
Labeling of Blood and
Blood Components
------------------------------------------------------------------------
Draft Guidance for June Do. Do. Do.
Industry: Recommendations 2000
for Donor Questioning
Regarding Possible
Exposure to Malaria
------------------------------------------------------------------------
Draft Guidance for June Do. Do. Do.
Industry: Pediatric 2000
Oncology Studies in
Response to a Written
Request
------------------------------------------------------------------------
Guidance for Industry: June Do. Do. Do.
Availability of Licensed 2000
Donor Screening Tests
Labeled for Use With
Cadaveric Blood Specimens
------------------------------------------------------------------------
Draft Guidance for June Do. Do. Do.
Industry: Chronic 2000
Cutaneous Ulcer and Burn
Wounds--Developing
Products for Treatment
------------------------------------------------------------------------
Draft Guidance for August Do. Do. Do.
Industry: Analytical 2000
Procedures and Methods
Validation--Chemistry,
Manufacturing, and
Controls Documentation
------------------------------------------------------------------------
Draft Guidance for August Do. Do. Do.
Industry: Considerations 2000
for Reproductive Toxicity
Studies for Preventive
Vaccines for Infectious
Disease Indications
------------------------------------------------------------------------
Guidance for Industry: Q & October Do. Do. Do.
A Content and Format of 2000
INDs for Phase 1 Studies
of Drugs, Including Well-
Characterized,
Therapeutic,
Biotechnology-Derived
Products
------------------------------------------------------------------------
Guidance for Industry: October Do. Do. Do.
Supplemental Guidance on 2000
Testing for Replication
Competent Retrovirus in
Retroviral Vector Based
Gene Therapy Products and
During Followup of
Patients in Clinical
Trials Using Retroviral
Vectors
------------------------------------------------------------------------
Guidance for Industry: October Do. Do. Do.
Submitting and Reviewing 2000
Complete Responses to
Clinical Holds
------------------------------------------------------------------------
Guidance for Industry: November Do. Do. Do.
Testing Limits in 2000
Stability Protocols for
Standardized Grass Pollen
Extracts
------------------------------------------------------------------------
Guidance for Industry: Use November Do. Do. Do.
of Sterile Connecting 2000
Devices in Blood Bank
Practices
------------------------------------------------------------------------
Draft Guidance for November Do. Do. Do.
Industry: Recommendations 2000
for Complying With the
Pediatric Rule (21 CFR
314.55(a) and 601.27(a))
------------------------------------------------------------------------
ICH Guidance for Industry: December Do. Do. Do.
E11 Clinical 2000
Investigation of
Medicinal Products in the
Pediatric Population
------------------------------------------------------------------------
Guidance for Industry: December Do. Do. Do.
Submitting Separate 2000
Marketing Applications
and Clinical Data for
Purposes of Assessing
User Fees
------------------------------------------------------------------------
ICH Guidance on Q6A December Do. Do. Do.
Specifications: Test 29,
Procedures and Acceptance 2000
Criteria for New Drug
Substances and New Drug
Products: Chemical
Substances
------------------------------------------------------------------------
PHS Guideline on January Do. Do. Do.
Infectious Disease Issues 19,
in Xenotransplantation 2001
------------------------------------------------------------------------
[[Page 835]]
Draft Guidance for January Do. Do. Do.
Industry: Pre-Storage 2001
Leukocyte Reduction of
Whole Blood and Blood
Components Intended for
Transfusion
------------------------------------------------------------------------
Guidance for Industry: January Do. Do. Do.
Recommendations for 2001
Collecting Red Blood
Cells by Automated
Apheresis Methods
------------------------------------------------------------------------
Draft Guidance for January Do. Do. Do.
Industry: Providing 2001
Regulatory Submissions in
Electronic Format--
Prescription Drug
Advertising and
Promotional Labeling
------------------------------------------------------------------------
Guidance for Industry: February Do. Do. Do.
Recommendations for 2001
Collecting Red Blood
Cells by Automated
Apheresis Methods--
Technical Correction
------------------------------------------------------------------------
Draft Guidance for February Do. Do. Do.
Industry: Disclosing 2001
Information Provided to
Advisory Committees in
Connection With Open
Advisory Committee
Meetings Related to the
Testing or Approval of
Biologic Products and
Convened by the Center
for Biologics Evaluation
and Research
------------------------------------------------------------------------
Draft Guidance for March Do. Do. Do.
Industry: Postmarketing 2001
Safety Reporting for
Human Drug and Biological
Products Including
Vaccines
------------------------------------------------------------------------
Guidance for Industry: March Do. Do. Do.
Acceptance of Foreign 2001
Clinical Studies
------------------------------------------------------------------------
Guidance for Industry: March Do. Do. Do.
Financial Disclosure by 2001
Clinical Investigators
------------------------------------------------------------------------
Guidance for Industry: March Do. Do. Do.
Monoclonal Antibodies 2001
Used as Reagents in Drug
Manufacturing
------------------------------------------------------------------------
Draft Guidance for April Do. Do. Do.
Industry: Reports on the 2001
Status of Postmarketing
Studies--Implementation
of Section 130 of the
Food and Drug
Administration
Modernization Act of 1997
------------------------------------------------------------------------
Draft Guidance for May 2001 Do. Do. Do.
Industry: Providing
Regulatory Submissions in
Electronic Format--
Postmarketing Expedited
Safety Reports
------------------------------------------------------------------------
Guidance for Industry: E10 May 2001 Do. Do. Do.
Choice of Control Group
and Related Issues in
Clinical Trials
------------------------------------------------------------------------
Draft Guidance for May 2001 Do. Do. Do.
Industry: IND Meetings
for Human Drugs and
Biologics; Chemistry,
Manufacturing, and
Controls Information
------------------------------------------------------------------------
Draft Guidance for July Do. Do. Do.
Industry: Clinical 2001
Studies Section of
Labeling for Prescription
Drugs and Biologics--
Content and Format
------------------------------------------------------------------------
Guidance for Industry: July Do. Do. Do.
CBER Pilot Licensing 2001
Program for Immunization
of Source Plasma Donors
Using Immunogen Red Blood
Cells Obtained From an
Outside Supplier
------------------------------------------------------------------------
Guidance for Industry: July Do. Do. Do.
Revised Recommendations 2001
Regarding Invalidation of
Test Results of Licensed
and 510(k) Cleared
Bloodborne Pathogen
Assays Used to Test
Donors
------------------------------------------------------------------------
ICH Guidance for Industry: July Do. Do. Do.
S7A Safety Pharmacology 2001
Studies for Human
Pharmaceuticals
------------------------------------------------------------------------
[[Page 836]]
Guidance for FDA July Do. Do. Do.
Reviewers: Premarket 2001
Notification Submissions
for Empty Containers for
the Collection and
Processing of Blood and
Blood Components
------------------------------------------------------------------------
Guidance for FDA July Do. Do. Do.
Reviewers: Premarket 2001
Notification Submissions
for Transfer Sets
(Excluding Sterile
Connecting Devices)
------------------------------------------------------------------------
Guidance for FDA July Do. Do. Do.
Reviewers: Premarket 2001
Notification Submissions
for Blood and Plasma
Warmers
------------------------------------------------------------------------
Guidance for Industry: July Do. Do. Do.
Changes to an Approved 2001
Application: Biological
Products: Human Blood and
Blood Components Intended
for Transfusion or for
Further Manufacture
------------------------------------------------------------------------
Draft Guidance for FDA August Do. Do. Do.
Reviewers: Premarket 2001
Notification Submissions
for Automated Testing
Instruments Used in Blood
Establishments
------------------------------------------------------------------------
Draft Guidance for August Do. Do. Do.
Industry: Biological 2001
Product Deviation
Reporting for Licensed
Manufacturers of
Biological Products Other
Than Blood and Blood
Components
------------------------------------------------------------------------
Draft Guidance for August Do. Do. Do.
Industry: Biological 2001
Product Deviation
Reporting for Blood and
Plasma Establishments
------------------------------------------------------------------------
Guidance for Industry: August Do. Do. Do.
Variances for Blood 2001
Collection From
Individuals With
Hereditary
Hemochromatosis
------------------------------------------------------------------------
Draft Guidance for August Do. Do. Do.
Industry: Submitting Type 2001
V Drug Master Files to
the CBER
------------------------------------------------------------------------
Draft Guidance for August Do. Do. Do.
Industry: Premarket 2001
Notifications (510(k)s)
for In Vitro HIV Drug
Resistance Genotype
Assays: Special Controls
------------------------------------------------------------------------
Draft Guidance for August Do. Do. Do.
Industry: Submitting 2001
Marketing Applications
According to the ICH-CTD
Format--General
Considerations
------------------------------------------------------------------------
ICH Guidance: Q7A Good August Do. Do. Do.
Manufacturing Practice 2001
Guide for Active
Pharmaceutical
Ingredients
------------------------------------------------------------------------
ICH Guidance on M4 Common August Do. Do. Do.
Technical Document 2001
------------------------------------------------------------------------
Guidance for Industry: October Do. Do. Do.
Cancer Drug and 2001
Biological Products--
Clinical Data in
Marketing Applications
------------------------------------------------------------------------
Guidance for Industry: October Do. Do. Do.
Content and Format of 2001
Geriatric Labeling
------------------------------------------------------------------------
Guidance for Industry: October Do. Do. Do.
Recommendations for 2001
Assessment of Donor
Suitability and Blood and
Blood Product Safety in
Cases of Possible
Exposure to Anthrax
------------------------------------------------------------------------
Draft Guidance for November Do. Do. Do.
Clinical Trial Sponsors 2001
on the Establishment and
Operation of Clinical
Trial Data Monitoring
Committees
------------------------------------------------------------------------
Guidance for Industry: November Do. Do. Do.
Information Request and 2001
Discipline Review Letters
Under the Prescription
Drug User Fee Act
------------------------------------------------------------------------
[[Page 837]]
Guidance for Industry: January Do. Do. Do.
Revised Preventive 2002
Measures to Reduce the
Possible Risk of
Transmission of
Creutzfeldt-Jakob Disease
(CJD) and Variant
Creutzfeldt-Jakob Disease
(vCJD) by Blood and Blood
Products
------------------------------------------------------------------------
Guidance for Industry: January Do. Do. Do.
General Principles of 2002
Software Validation;
Final Guidance for
Industry and FDA Staff
------------------------------------------------------------------------
Draft Guidance for February Do. Do. Do.
Industry: Precautionary 2002
Measures to Reduce the
Possible Risk of
Transmission of Zoonoses
by Blood and Blood
Products From
Xenotransplantation
Product Recipients and
Their Intimate Contacts
------------------------------------------------------------------------
Guidance for Industry: March Do. Do. Do.
Validation of Procedures 2002
for Processing of Human
Tissues Intended for
Transplantation
------------------------------------------------------------------------
Guidance for Industry; March Do. Do. http://
Information Program on 2002 www.fda.g
Clinical Trials for ov/cber/
Serious or Life- gdlns/
Threatening Diseases and clintrial
Conditions 031802.pd
f
------------------------------------------------------------------------
Guidance for Industry: March Do. Do. http://
Providing Regulatory 2002 www.fda.g
Submissions to CBER in ov/cber/
Electronic Format-- guideline
Investigational New Drug s.htm
Applications (INDs)
------------------------------------------------------------------------
Guidance for Industry: April Do. Do. Do.
E2BM Data Elements for 2002
Transmission of
Individual Case Safety
Reports
------------------------------------------------------------------------
Draft Guidance for April Do. Do. Do.
Industry: A Modified Lot- 2002
Release Specification for
Hepatitis B Surface
Antigen (HBsAg) Assays
Used to Test Blood, Blood
Components, and Source
Plasma Donations
------------------------------------------------------------------------
Guidance for Industry: May 1999 Do. Do. Do.
Container Closure Systems
for Packaging Human Drugs
and Biologics; Chemistry,
Manufacturing, and
Controls Documentation
------------------------------------------------------------------------
Guidance for Industry: May 2002 Do. Do. Do.
Container Closure Systems
for Packaging Human Drugs
and Biologics; Questions
and Answers
------------------------------------------------------------------------
Draft Guidelines for May 2002 Do. Do. Do.
Ensuring the Quality of
Information Disseminated
to the Public (HHS
Guideline)
------------------------------------------------------------------------
Guidance for Industry: May 2002 Do. Do. Do.
Special Protocol
Assessment
------------------------------------------------------------------------
Draft Guidance for June Do. Do. Do.
Industry: Preventive 2002
Measures to Reduce the
Possible Risk of
Transmission of
Creutzfeldt-Jakob Disease
(CJD) and Variant
Creutzfeldt-Jakob Disease
(vCJD) by Human Cells,
Tissues, and Cellular and
Tissue-Based Products
(HCT/Ps)
------------------------------------------------------------------------
Draft Guidance for August Do. Do. Do.
Industry: 21 CFR Part 11; 2002
Electronic Records;
Electronic Signatures,
Electronic Copies of
Electronic Records
------------------------------------------------------------------------
Guidance for Industry: August Do. Do. Do.
Establishing Pregnancy 2002
Exposure Registries
------------------------------------------------------------------------
Draft Guidance for Septembe Do. Do. Do.
Industry: Drugs, r 2002
Biologics, and Medical
Devices Derived From
Bioengineered Plants for
Use in Humans and Animals
------------------------------------------------------------------------
Draft Guidance for Septembe Do. Do. Do.
Industry: Nonclinical r 2002
Studies for Development
of Pharmaceutical
Excipients
------------------------------------------------------------------------
[[Page 838]]
The Least Burdensome October Do. Do. Do.
Provisions of the FDA 2002
Modernization Act of
1997: Concept and
Principles; Final
Guidance for FDA and
Industry
------------------------------------------------------------------------
Guidance for Industry and December Do. Do. http://
FDA Staff; Class II 18, www.fda.g
Special Controls Guidance 2003 ov/cber/
Document: Human Dura gdlns/
Mater humdurama
t.pdf
------------------------------------------------------------------------
Guidance for Industry: December Do. Do. http://
Recommendations for 2002 www.fda.g
Deferral of Donors and ov/cber/
Quarantine and Retrieval guideline
of Blood and Blood s.htm
Products in Recent
Recipients of Smallpox
Vaccine (Vaccinia Virus)
and Certain Contacts of
Smallpox Vaccine
Recipients
------------------------------------------------------------------------
Draft Guidance for December Do. Do. Do.
Industry and Reviewers on 2002
Estimating the Safe
Starting Dose in Clinical
Trials for Therapeutics
in Adult Healthy
Volunteers
------------------------------------------------------------------------
ICH Guidance for Industry; January Do. Do. Do.
Q1D Bracketing and 2003
Matrixing Designs for
Stability Testing of New
Drug Substances and
Products
------------------------------------------------------------------------
Draft Guidance for January Do. Do. Do.
Industry: Collection of 2003
Race and Ethnicity Data
in Clinical Trials
------------------------------------------------------------------------
Draft Guidance for January Do. Do. Do.
Industry: Drug Product: 2003
Chemistry, Manufacturing,
and Controls Information
------------------------------------------------------------------------
ICH Guidance for Industry: February Do. Do. Do.
M4 CTD--Safety: Questions 2003
and Answers
------------------------------------------------------------------------
Guidance for Industry and February Do. Do. Do.
FDA Staff: Quality System 2003
Information for Certain
Premarket Application
Reviews
------------------------------------------------------------------------
ICH Guidance for Industry: February Do. Do. Do.
Q3A Impurities in New 2003
Drug Substances
------------------------------------------------------------------------
Draft Guidance for February Do. Do. Do.
Industry; Comparability 2003
Protocols--Chemistry,
Manufacturing, and
Controls Information
------------------------------------------------------------------------
Assessing User Fees: PMA February Do. Do. http://
Supplement Definitions, 25, www.fda.g
Modular PMA Fees, BLA and 2003 ov/cber/
Efficacy Supplement dap/
Definitions, Bundling devpubs.h
Multiple Devices in a tm
Single Application, and
Fees for Combination
Products; Guidance for
Industry and FDA
------------------------------------------------------------------------
Guidance for Industry and March Do. Do. http://
FDA: FY 2003 MDUFMA Small 2003 www.fda.g
Business Qualification ov/cber/
Worksheet and guideline
Certification s.htm
------------------------------------------------------------------------
ICH Guidance for Industry: April Do. Do. Do.
M2 eCTD: Electronic 2003
Common Technical Document
Specification
------------------------------------------------------------------------
Guidance for Industry: April Do. Do. Do.
Source Animal, Product, 2003
Preclinical, and Clinical
Issues Concerning the Use
of Xenotransplantation
Products in Humans
------------------------------------------------------------------------
Guidance for Industry: April Do. Do. Do.
Recommendations for the 2003
Assessment of Donor
Suitability and Blood
Product Safety in Cases
of Suspected Severe Acute
Respiratory Syndrome
(SARS) or Exposure to
SARS
------------------------------------------------------------------------
Guidance for Industry, FDA October Do. Do. http://
Staff, and Third Parties; 4, 2004 www.fda.g
Implementation of the ov/cber/
Inspection by Accredited dap/
Persons Program Under the devpubs.h
Medical Device User Fee tm
and Modernization Act of
2002; Accreditation
Criteria
------------------------------------------------------------------------
[[Page 839]]
Guidance for Industry: April Do. Do. http://
Exposure-Response 2003 www.fda.g
Relationships--Study ov/cber/
Design, Data Analysis, guideline
and Regulatory s.htm
Applications
------------------------------------------------------------------------
Guidance for Industry: May 2003 Do. Do. Do.
Revised Recommendations
for the Assessment of
Donor Suitability and
Blood and Blood Product
Safety in Cases of Known
or Suspected West Nile
Virus Infection
------------------------------------------------------------------------
Guidance for Industry: May 2003 Do. Do. Do.
Pharmacokinetics in
Patients With Impaired
Hepatic Function: Study
Design, Data Analysis,
and Impact on Dosing and
Labeling
------------------------------------------------------------------------
Draft Guidance for June Do. Do. Do.
Industry and FDA Staff: 2003
Compliance with Section
301 of the Medical Device
User Fee and
Modernization Act of
2002--Identification of
Manufacturer of Medical
Devices
------------------------------------------------------------------------
Guidance for FDA Staff: June Do. Do. Do.
The Leveraging Handbook, 2003
An Agency Resource for
Effective Collaborations
------------------------------------------------------------------------
Draft Guidance for June Do. Do. Do.
Industry: Providing 2003
Regulatory Submissions in
Electronic Format--
Postmarketing Periodic
Adverse Drug Experience
Reports
------------------------------------------------------------------------
Draft Guidance for June Do. Do. Do.
Industry: Revised 2003
Recommendations for Donor
and Product Management
Based on Screening Tests
for Syphilis
------------------------------------------------------------------------
Guidance for Industry and July Do. Do. Do.
FDA Staff: Medical Device 2003
User Fee and
Modernization Act of
2002, Validation Data in
Premarket Notification
Submissions (510(k)s) for
Reprocessed Single-Use
Medical Devices
------------------------------------------------------------------------
Guidance for Industry: July Do. Do. Do.
Streamlining the Donor 2003
Interview Process:
Recommendations for Self-
Administered
Questionnaires
------------------------------------------------------------------------
Draft Guidance for July Do. Do. Do.
Industry and FDA Staff: 2003
Premarket Assessment of
Pediatric Medical Devices
------------------------------------------------------------------------
Draft Guidance for Review July Do. Do. Do.
Staff and Industry: Good 2003
Review Management
Principles for PDUFA
Products
------------------------------------------------------------------------
Compliance Program Dates Do. Do. http://
Guidance Manual (drugs vary--I www.fda.g
and biologics) ndividu ov/cber/
al cpg/
issue cpg.htm
dates
------------------------------------------------------------------------
ICH Guidance for Industry: November Do. Do. http://
Q3C--Tables and List 2003 www.fda.g
ov/cber/
guideline
s.htm
------------------------------------------------------------------------
ICH Guidance for Industry: November Do. Do. Do.
Q3B(R) Impurities in New 2003
Drug Products
------------------------------------------------------------------------
ICH Guidance for Industry: November Do. Do. Do.
Q1A(R2) Stability Testing 2003
of New Drug Substances
and Products
¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤
WITHDRAWN GUIDANCES
------------------------------------------------------------------------
Draft Guidance for November Do. N/A
Industry: Application of 1999
Current Statutory
Authority to Nucleic Acid
Testing of Pooled Plasma
------------------------------------------------------------------------
Draft Document Concerning December Do. Do.
the Regulation of 1995
Placental/Umbilical Cord
Blood Hematopoietic Stem
Cell Products Intended
for Transplantation or
Further Manufacturing
Into Injectable Products
------------------------------------------------------------------------
[[Page 840]]
Draft Document Concerning February Do. Do.
the Regulation of 1996
Peripheral Blood
Hematopoietic Stem Cell
Products Intended for
Transplantation or
Further Manufacturing
into Injectable Products
------------------------------------------------------------------------
Draft Advertising and August Do. Do.
Promotional Labeling 1994
Staff Procedural Guidance
------------------------------------------------------------------------
Draft Guidance for August Do. Do.
Industry: 21 CFR Part 11; 2001
Electronic Records;
Electronic Signatures;
Validation
------------------------------------------------------------------------
Draft Guidance for August Do. Do.
Industry: 21 CFR Part 11; 2001
Electronic Records;
Electronic Signatures;
Glossary of Terms
------------------------------------------------------------------------
Draft Guidance for February Do. Do.
Industry: 21 CFR Part 11; 2002
Electronic Records;
Electronic Signatures;
Time Stamps
------------------------------------------------------------------------
Draft Guidance for July Do. Do.
Industry: 21 CFR Part 11; 2002
Electronic Records;
Electronic Signatures,
Maintenance of Electronic
Records
------------------------------------------------------------------------
Guidance Documents Issued by CDER
------------------------------------------------------------------------
How to Obtain a Copy
Intended of the Document
Name of Document Date of User or -----------------------
Issuance Regulatory Mailing Internet
Activity Address Address
------------------------------------------------------------------------
Aerosol Steroid Product January Advertisin Division http://
Safety Information in 12, g of Drug www.fda.g
Prescription Drug 1998 Informati ov/cder/
Advertising and on (HFD- guidance/
Promotional Labeling 200), index.htm
Office of
Training
and
Communica
tions,
Center
for Drug
Evaluatio
n and
Research,
Food and
Drug
Administr
ation,
5600
Fishers
Lane,
Rockville
, MD
20857,
301-827-4
573
------------------------------------------------------------------------
Consumer-Directed August Do. Do. Do.
Broadcast Advertisements 9, 1999
------------------------------------------------------------------------
Industry-Supported December Do. Do. Do.
Scientific and 3, 1997
Educational Activities
------------------------------------------------------------------------
Accelerated Approval March Advertisin Do. Do.
Products--Submission of 26, g draft
Promotional Materials 1999
------------------------------------------------------------------------
Brief Summary: Disclosing February Do. Do. Do.
Risk Information in 10,
Consumer-Directed Print 2004
Advertisements
------------------------------------------------------------------------
``Help-Seeking'' and Other February Do. Do. Do.
Disease Awareness 10,
Communications by or on 2004
Behalf of Drug and Device
Firms
------------------------------------------------------------------------
Product Name Placement, March Do. Do. Do.
Size, and Prominence in 12,
Advertising and 1999
Promotional Labeling
------------------------------------------------------------------------
Promoting Medical Products January Do. Do. Do.
in a Changing Healthcare 5, 1998
Environment; I. Medical
Product Promotion by
Healthcare Organizations
or Pharmacy Benefits
Management Companies
(PBMs)
------------------------------------------------------------------------
Bioanalytical Method May 23, Biopharmac Do. Do.
Validation 2001 eutics
------------------------------------------------------------------------
[[Page 841]]
Bioavailability and March Do. Do. Do.
Bioequivalence Studies 19,
for Orally Administered 2003
Drug Products--General
Considerations
------------------------------------------------------------------------
Cholestyramine Powder In July 15, Do. Do. Do.
Vitro Bioequivalence 1993
------------------------------------------------------------------------
Clozapine Tablets In Vivo November Do. Do. Do.
Bioequivalence and In 15,
Vitro Dissolution Testing 1996
------------------------------------------------------------------------
Corticosteroids, June 2, Do. Do. Do.
Dermatologic (topical) In 1995
Vivo
------------------------------------------------------------------------
Dissolution Testing of August Do. Do. Do.
Immediate Release Solid 25,
Oral Dosage Forms 1997
------------------------------------------------------------------------
Extended Release Oral Septembe Do. Do. Do.
Dosage Forms: r 26,
Development, Evaluation, 1997
and Application of In
Vitro/In Vivo
Correlations
------------------------------------------------------------------------
Food-Effect December Do. Do. Do.
Bioavailability and Fed 2002
Bioequivalence Studies
------------------------------------------------------------------------
Metaproterenol Sulfate and June 27, Do. Do. Do.
Albuterol Metered Dose 1989
Inhalers In Vitro
------------------------------------------------------------------------
Phenytoin/Phenytion Sodium March 4, Do. Do. Do.
(capsules, tablets, 1994
suspension) In Vivo
Bioequivalence and In
Vitro Dissolution Testing
------------------------------------------------------------------------
Statistical Approaches to February Do. Do. Do.
Establishing 2, 2001
Bioequivalence
------------------------------------------------------------------------
Waiver of In Vivo August Do. Do. Do.
Bioavailability and 31,
Bioequivalence Studies 2000
for Immediate-Release
Solid Oral Dosage Forms
Based on a
Biopharmaceutics
Classification System
------------------------------------------------------------------------
Antifungal (topical) February Biopharmac Do. N/A
24, eutics
1990 draft
------------------------------------------------------------------------
Antifungal (vaginal) February Do. Do. Do.
24,
1990
------------------------------------------------------------------------
Bioavailability and April Do. Do. http://
Bioequivalence Studies 2003 www.fda.g
for Nasal Aerosols and ov/cder/
Nasal Sprays for Local guidance/
Action index.htm
------------------------------------------------------------------------
Clozapine Tablets: In Vivo December Do. Do. Do.
Bioequivalence and In 2003
Vitro Dissolution Testing
------------------------------------------------------------------------
Conjugated Estrogens, USP- March Do. Do. Do.
LC-MS Method for Both 2000
Qualitative Chemical
Characterization and
Documentation of
Qualitative
Pharmaceutical
Equivalence
------------------------------------------------------------------------
BACPAC I: Intermediates in February Chemistry Do. http://
Drug Substance Synthesis: 16, www.fda.g
Bulk Actives Postapproval 2001 ov/cder/
Changes: Chemistry, guidance/
Manufacturing, and index.htm
Controls Documentation
------------------------------------------------------------------------
Changes to an Approved July 24, Do. Do. Do.
Application for Specified 1997
Biotechnology and
Specified Synthetic
Biological Products
------------------------------------------------------------------------
Changes to an Approved NDA April Do. Do. Do.
or ANDA 2004
------------------------------------------------------------------------
Changes to an Approved NDA January Do. Do. Do.
or ANDA: Questions and 22,
Answers 2001
------------------------------------------------------------------------
Container Closure Systems May 1999 Do. Do. Do.
for Packaging Human Drugs
and Biologics
------------------------------------------------------------------------
[[Page 842]]
Demonstration of April Do. Do. Do.
Comparability of Human 1996
Biological Products,
Including Therapeutic
Biotechnology-Derived
Products
------------------------------------------------------------------------
Development of New May 1, Do. Do. Do.
Stereoisomeric Drugs 1992
------------------------------------------------------------------------
Drug Master Files Septembe Do. Do. Do.
r 1,
1989
------------------------------------------------------------------------
Drug Master Files for Bulk November Do. Do. Do.
Antibiotic Drug 29,
Substances 1999
------------------------------------------------------------------------
Environmental Assessment July 27, Do. Do. Do.
of Human Drug and 1998
Biologics Applications
------------------------------------------------------------------------
Format and Content for the Septembe Do. Do. Do.
CMC Section of an Annual r 1,
Report 1994
------------------------------------------------------------------------
Format and Content of the February Do. Do. Do.
Chemistry, Manufacturing, 1, 1987
and Controls Section of
an Application
------------------------------------------------------------------------
Format and Content of the February Do. Do. Do.
Microbiology Section of 1, 1987
an Application
------------------------------------------------------------------------
IND Meetings for Human May 25, Do. Do. Do.
Drugs and Biologics; 2001
Chemistry, Manufacturing,
and Controls Information
------------------------------------------------------------------------
INDs for Phase 2 and 3 May 20, Do. Do. Do.
Studies; Chemistry, 2003
Manufacturing, and
Controls Information
------------------------------------------------------------------------
Monoclonal Antibodies Used March Do. Do. Do.
as Reagents in Drug 29,
Manufacturing 2001
------------------------------------------------------------------------
Nasal Spray and Inhalation July 5, Do. Do. Do.
Solution, Suspension, and 2002
Spray Drug Products--
Chemistry, Manufacturing,
and Controls
Documentation
------------------------------------------------------------------------
NDAs: Impurities in Drug February Do. Do. Do.
Substances 25,
2000
------------------------------------------------------------------------
PAC-ALTS: Postapproval April Do. Do. Do.
Changes--Analytical 28,
Testing Laboratory Sites 1998
------------------------------------------------------------------------
Reviewer Guidance: November Do. Do. Do.
Validation of 1994
Chromatographic Methods
------------------------------------------------------------------------
Submission Documentation November Do. Do. Do.
for Sterilization Process 1, 1994
Validation in
Applications for Human
and Veterinary Drug
Products
------------------------------------------------------------------------
Submission of Chemistry, November Do. Do. Do.
Manufacturing, and 1994
Controls Information for
Synthetic Peptide
Substances
------------------------------------------------------------------------
Submitting Documentation February Do. Do. Do.
for the Manufacturing of, 1, 1987
and Controls for, Drug
Products
------------------------------------------------------------------------
Submitting Documentation February Do. Do. Do.
for the Stability of 1, 1987
Human Drugs and Biologics
------------------------------------------------------------------------
Submitting Samples and February Do. Do. Do.
Analytical Data for 1987
Methods Validation
------------------------------------------------------------------------
Submitting Supporting February Do. Do. N/A
Documentation in Drug 1, 1987
Applications for the
Manufacture of Drug
Products
------------------------------------------------------------------------
Submitting Supporting February Do. Do. http://
Documentation in Drug 1987 www.fda.g
Applications for the ov/cder/
Manufacture of Drug guidance/
Substances index.htm
------------------------------------------------------------------------
[[Page 843]]
SUPAC IR--Immediate- November Do. Do. Do.
Release Solid Oral Dosage 1995
Forms: Scale-Up and
Postapproval Changes:
Chemistry, Manufacturing
and Controls, In Vitro
Dissolution Testing, and
In Vivo Bioequivalence
Documentation
------------------------------------------------------------------------
SUPAC IR/MR: Immediate January Do. Do. Do.
Release and Modified 1999
Release Solid Oral Dosage
Forms Manufacturing
Equipment Addendum
------------------------------------------------------------------------
SUPAC-IR Questions and February Do. Do. Do.
Answers About SUPAC-IR 18,
Guidance 1997
------------------------------------------------------------------------
SUPAC-MR: Modified Release October Do. Do. Do.
Solid Oral Dosage Forms 6, 1997
Scale-Up and Postapproval
Changes: Chemistry,
Manufacturing, and
Controls; In Vitro
Dissolution Testing and
In Vivo Bioequivalence
Documentation
------------------------------------------------------------------------
SUPAC-SS--Nonsterile May 1997 Do. Do. Do.
Semisolid Dosage Forms
Scale-Up and Postapproval
Changes: Chemistry,
Manufacturing, and
Controls; In Vitro
Release Testing and In
Vivo Bioequivalence
Documentation
------------------------------------------------------------------------
The Sourcing and December Do. Do. Do.
Processing of Gelatin to 20,
Reduce the Potential Risk 2000
Posed by Bovine
Spongiform Encephalopathy
(BSE)
------------------------------------------------------------------------
Analytical Procedures and August Chemistry Do. Do.
Methods Validation: 30, draft
Chemistry, Manufacturing, 2000
and Controls
Documentation
------------------------------------------------------------------------
Botanical Drug Products June 9, Do. Do. Do.
2004
------------------------------------------------------------------------
Comparability Protocols-- February Do. Do. Do.
Chemistry, Manufacturing, 25,
and Controls Information 2003
------------------------------------------------------------------------
Drug Product: Chemistry, January Do. Do. Do.
Manufacturing, and 28,
Controls Information 2003
------------------------------------------------------------------------
Drug Substance: Chemistry, January Do. Do. Do.
Manufacturing, and 7, 2004
Controls Information
------------------------------------------------------------------------
Drugs, Biologics, and Septembe Do. Do. Do.
Medical Devices Derived r 2002
From Bioengineered Plants
for Use in Humans and
Animals
------------------------------------------------------------------------
Interpreting Sameness of July Do. .......... Do.
Monoclonal Antibody 1999
Products Under the Orphan
Drug Regulations
------------------------------------------------------------------------
Liposome Drug Products: August Do. Do. Do.
Chemistry, Manufacturing, 2002
and Controls; Human
Pharmacokinetics and
Bioavailability; and
Labeling Documentation
------------------------------------------------------------------------
Metered Dose Inhaler (MDI) November Do. Do. Do.
and Dry Powder Inhaler 19,
(DPI) Drug Products; 1998
Chemistry, Manufacturing,
and Controls
Documentation
------------------------------------------------------------------------
Stability Testing of Drug June 8, Do. Do. Do.
Substances and Drug 1998
Products
------------------------------------------------------------------------
Submitting Supporting November Do. Do. N/A
Chemistry Documentation 1, 1991
in Radiopharmaceutical
Drug Applications
------------------------------------------------------------------------
SUPAC-SS: Nonsterile January Do. Do. http://
Semisolid Dosage Forms 5, 1999 www.fda.g
Manufacturing Equipment ov/cder/
Addendum guidance/
index.htm
------------------------------------------------------------------------
[[Page 844]]
Antiretroviral Drugs Using October Clinical Do. Do.
Plasma HIV RNA 2002 antimicro
Measurements--Clinical bial
Considerations for
Accelerated and
Traditional Approval
------------------------------------------------------------------------
Clinical Development and October Do. Do. Do.
Labeling of Anti- 26,
Infective Drug Products 1992
------------------------------------------------------------------------
Clinical Evaluation of Septembe Do. Do. Do.
Anti-Infective Drugs r 1,
(Systemic) 1977
------------------------------------------------------------------------
Preclinical Development of November Do. Do. Do.
Antiviral Drugs 1990
------------------------------------------------------------------------
Acute Bacterial July 22, Clinical Do. Do.
Exacerbation of Chronic 1998 antimicro
Bronchitis; Developing bial
Antimicrobial Drugs for draft
Treatment
------------------------------------------------------------------------
Acute Bacterial July 22, Do. Do. Do.
Meningitis; Developing 1998
Antimicrobial Drugs for
Treatment
------------------------------------------------------------------------
Acute Bacterial Sinusitis; July 22, Do. Do. Do.
Developing Antimicrobial 1998
Drugs for Treatment
------------------------------------------------------------------------
Acute or Chronic Bacterial July 22, Do. Do. Do.
Prostatitis; Developing 1998
Antimicrobial Drugs for
Treatment
------------------------------------------------------------------------
Acute Otitis Media; July 22, Do. Do. Do.
Developing Antimicrobial 1998
Drugs for Treatment
------------------------------------------------------------------------
Bacterial Vaginosis; July 22, Do. Do. Do.
Developing Antimicrobial 1998
Drugs for Treatment
------------------------------------------------------------------------
Catheter-Related October Do. Do. Do.
Bloodstream Infections-- 18,
Developing Antimicrobial 1999
Drugs for Treatment
------------------------------------------------------------------------
Community Acquired July 22, Do. Do. Do.
Pneumonia; Developing 1998
Antimicrobial Drugs for
Treatment
------------------------------------------------------------------------
Complicated Urinary Tract July 22, Do. Do. Do.
Infections and 1998
Pylonephritis--Developing
Antimicrobial Drugs for
Treatment
------------------------------------------------------------------------
Developing Antimicrobial July 22, Do. Do. Do.
Drugs--General 1998
Considerations for
Clinical Trials
------------------------------------------------------------------------
Developing Drugs to Treat March Do. Do. Do.
Inhalational Anthrax 18,
(Post-Exposure) 2002
------------------------------------------------------------------------
Empiric Therapy of Febrile July 22, Do. Do. Do.
Neutropenia--Developing 1998
Antimicrobial Drugs for
Treatment
------------------------------------------------------------------------
Evaluating Clinical February Do. Do. Do.
Studies of Antimicrobials 1997
in the Division of Anti-
Infective Drug Products
------------------------------------------------------------------------
Lyme Disease--Developing July 22, Do. Do. Do.
Antimicrobial Drugs for 1998
Treatment
------------------------------------------------------------------------
Nosocomial Pneumonia-- July 22, Do. Do. Do.
Developing Antimicrobial 1998
Drugs for Treatment
------------------------------------------------------------------------
Secondary Bacterial July 22, Do. Do. Do.
Infections of Acute 1998
Bronchitis--Developing
Antimicrobial Drugs for
Treatment
------------------------------------------------------------------------
Streptococcal Pharyngitis July 22, Do. Do. Do.
and Tonsillitis-- 1998
Developing Antimicrobial
Drugs for Treatment
------------------------------------------------------------------------
Uncomplicated and July 22, Do. Do. Do.
Complicated Skin and Skin 1998
Structure Infections--
Developing Antimicrobial
Drugs for Treatment
------------------------------------------------------------------------
[[Page 845]]
Uncomplicated Gonorrhea-- July 22, Do. Do. Do.
Developing Antimicrobial 1998
Drugs for Treatment
------------------------------------------------------------------------
Uncomplicated Urinary July 22, Do. Do. Do.
Tract Infections-- 1998
Developing Antimicrobial
Drugs for Treatment
------------------------------------------------------------------------
Vaccinia Virus--Developing March Do. Do. Do.
Drugs to Mitigate 2004
Complications From
Smallpox Vaccination
------------------------------------------------------------------------
Vuvlovaginal Candidiasis-- July 22, Do. Do. Do.
Developing Antimicrobial 1998
Drugs for Treatment
------------------------------------------------------------------------
Acceptance of Foreign March Clinical Do. Do.
Clinical Studies 2001 medical
------------------------------------------------------------------------
Calcium DTPA and Zinc DTPA August Do. Do. Do.
Drug Products--Submitting 2004
a New Drug Application
------------------------------------------------------------------------
Cancer Drug and Biological October Do. Do. Do.
Products--Clinical Data 2001
in Marketing Applications
------------------------------------------------------------------------
Clinical Development February Do. Do. Do.
Programs for Drugs, 1999
Devices, and Biological
Products for the
Treatment of Rheumatoid
Arthritis (RA)
------------------------------------------------------------------------
Clinical Development Septembe Do. Do. Do.
Programs for MDI and DPI r 19,
Drug Products 1994
------------------------------------------------------------------------
Clinical Evaluation of April Do. Do. Do.
Anti-Inflammatory and 1988
Antirheumatic Drugs
(adults and children)
------------------------------------------------------------------------
Clinical Evaluation of Septembe Do. Do. Do.
Antianxiety Drugs r 1,
1977
------------------------------------------------------------------------
Clinical Evaluation of Septembe Do. Do. Do.
Antidepressant Drugs r 1,
1977
------------------------------------------------------------------------
Clinical Evaluation of January Do. Do. Do.
Antiepileptic Drugs 1, 1981
(adults and children)
------------------------------------------------------------------------
Clinical Evaluation of May 1, Do. Do. Do.
General Anesthetics 1982
------------------------------------------------------------------------
Clinical Evaluation of Septembe Do. Do. Do.
Hypnotic Drugs r 1,
1977
------------------------------------------------------------------------
Clinical Evaluation of May 1982 Do. Do. Do.
Local Anesthetics
------------------------------------------------------------------------
Clinical Evaluation of July Do. Do. Do.
Psychoactive Drugs in 1979
Infants and Children
------------------------------------------------------------------------
Content and Format for May 1996 Do. Do. Do.
Pediatric Use Supplements
------------------------------------------------------------------------
Content and Format of November Do. Do. Do.
Investigational New Drug 1995
Applications (INDs) for
Phase 1 Studies of Drugs,
Including Well-
Characterized,
Therapeutic,
Biotechnology-Derived
Products
------------------------------------------------------------------------
Establishing Pregnancy August Do. Do. Do.
Exposure Registries 2002
------------------------------------------------------------------------
FDA Approval of New Cancer February Do. Do. Do.
Treatment Uses for 2, 1999
Marketed Drug and
Biological Products
------------------------------------------------------------------------
FDA Requirements for January Do. Do. Do.
Approval of Drugs to 1991
Treat Non-Small Cell Lung
Cancer
------------------------------------------------------------------------
Format and Content of the July 1, Do. Do. Do.
Clinical and Statistical 1988
Sections of an
Application
------------------------------------------------------------------------
Format and Content of the February Do. Do. Do.
Summary for New Drug and 1, 1987
Antibiotic Applications
------------------------------------------------------------------------
Formatting, Assembling and February Do. Do. Do.
Submitting New Drug and 1, 1987
Antiobiotic Applications
------------------------------------------------------------------------
[[Page 846]]
General Considerations for December Do. Do. Do.
the Clinical Evaluation 1, 1978
of Drugs
------------------------------------------------------------------------
General Considerations for Septembe Do. Do. Do.
the Clinical Evaluation r 1,
of Drugs in Infants and 1977
Children
------------------------------------------------------------------------
Guidance for the April Do. Do. Do.
Development of Vaginal 1995
Contraceptive Drugs (NDA)
------------------------------------------------------------------------
IND Exemptions for Studies January Do. Do. Do.
of Lawfully Marketed Drug 15,
or Biological Products 2004
for the Treatment of
Cancer
------------------------------------------------------------------------
Integration of Dose- March Do. Do. Do.
Counting Mechanisms Into 2003
MDI Drug Products
------------------------------------------------------------------------
Levothyroxine Sodium March 8, Do. Do. Do.
Tablets--In Vivo 2001
Pharmacokinetic and
Bioavailability Studies
and In Vitro Dissolution
Testing
------------------------------------------------------------------------
Oncologic Drugs Advisory April Do. Do. Do.
Committee Discussion on 19,
FDA Requirements for 1988
Approval of New Drugs for
Treatment of Colon and
Rectal Cancer
------------------------------------------------------------------------
Oncologic Drugs Advisory April Do. Do. Do.
Committee Discussion on 1988
FDA Requirements for
Approval of New Drugs for
Treatment of Ovarian
Cancer
------------------------------------------------------------------------
Postmarketing Adverse August Do. Do. Do.
Experience Reporting for 27,
Human Drug and Licensed 1997
Biological Products:
Clarification of What to
Report
------------------------------------------------------------------------
Postmarketing Reporting of March 1, Do. Do. Do.
Adverse Drug Experiences 1992
------------------------------------------------------------------------
Preclinical Development of Septembe Do. Do. Do.
Immunomodulatory Drugs r 1992
for Treatment of HIV
Infection and Associated
Disorders
------------------------------------------------------------------------
Preparation of November Do. Do. Do.
Investigational New Drug 1, 1992
Products (Human and
Animal)
------------------------------------------------------------------------
Providing Clinical May 1998 Do. Do. Do.
Evidence of Effectiveness
for Human Drug and
Biological Products
------------------------------------------------------------------------
Prussian Blue Drug February Do. Do. Do.
Products--Submitting a 4, 2003
New Drug Application
------------------------------------------------------------------------
Study and Evaluation of July 22, Do. Do. Do.
Gender Differences in the 1993
Clinical Evaluation of
Drugs
------------------------------------------------------------------------
Study of Drugs Likely to November Do. Do. Do.
be Used in the Elderly 1, 1989
------------------------------------------------------------------------
Submission of Abbreviated Septembe Do. Do. Do.
Reports and Synopses in r 13,
Support of Marketing 1999
Applications
------------------------------------------------------------------------
Abuse Liability Assessment July 1, Clinical Do. N/A
1990 medical
draft
------------------------------------------------------------------------
Allergic Rhinitis: June 21, Do. Do. http://
Clinical Development 2000 www.fda.g
Programs for Drug ov/cder/
Products guidance/
index.htm
--------------------------------------
------------------------------------------------------------------------
Chronic Cutaneous Ulcer June 28, Do. Do. Do.
and Burn Wounds-- 2000
Developing Products for
Treatment
------------------------------------------------------------------------
[[Page 847]]
Clinical Development July Do. Do. Do.
Programs for Drugs, 1999
Devices, and Biological
Products Intended for the
Treatment of
Osteoarthritis (OA)
------------------------------------------------------------------------
Clinical Evaluation of January Do. Do. N/A
Anti-Anginal Drugs 1, 1989
------------------------------------------------------------------------
Clinical Evaluation of July 1, Do. Do. Do.
Anti-Arrhythmic Drugs 1985
------------------------------------------------------------------------
Clinical Evaluation of May 1, Do. Do. Do.
Antihypertensive Drugs 1988
------------------------------------------------------------------------
Clinical Evaluation of December Do. Do. Do.
Drugs for the Treatment 1, 1987
of Congestive Heart
Failure
------------------------------------------------------------------------
Clinical Evaluation of Septembe Do. Do. http://
Lipid-Altering Agents in r 1990 www.fda.g
Adults and Children ov/cder/
guidance/
index.htm
------------------------------------------------------------------------
Clinical Evaluation of Septembe Do. Do. Do.
Weight-Control Drugs r 24,
1996
------------------------------------------------------------------------
Clinical Trial Sponsors on November Do. Do. Do.
the Establishment and 2001
Operation of Clinical
Trial Data Monitoring
Committees
------------------------------------------------------------------------
Collection of Race and January Do. Do. Do.
Ethnicity Data in 30,
Clinical Trials for FDA- 2003
Regulated Products
------------------------------------------------------------------------
Developing Medical Imaging May 19, Do. Do. Do.
Drug and Biological 2003
Products--2nd draft
------------------------------------------------------------------------
Development and Evaluation February Do. Do. N/A
of Drugs for the 12,
Treatment of Psychoactive 1992
Substance Use Disorders
------------------------------------------------------------------------
Development of Parathyroid May 2000 Do. Do. http://
Hormone for the www.fda.g
Prevention and Treatment ov/cder/
of Osteoporosis guidance/
index.htm
------------------------------------------------------------------------
Drugs, Biologics, and Septembe Do. Do. Do.
Medical Devices Derived r 2002
From Bioengineered Plants
for Use in Humans and
Animals
------------------------------------------------------------------------
Estrogen and Estrogen/ January Do. Do. Do.
Progestin Drug Products 2003
to Treat Vasomotor
Symptoms and Vulvar and
Vaginal Atrophy Symptoms--
Recommendations for
Clinical Evaluation
------------------------------------------------------------------------
Evaluation of Human June Do. Do. Do.
Pregnancy Outcome Data 1999
------------------------------------------------------------------------
Evaluation of the Effects November Do. Do. Do.
of Orally Inhaled and 6, 2001
Intranasal
Corticosteroids on Growth
in Children
------------------------------------------------------------------------
Exercise-Induced February Do. Do. Do.
Bronchospasm (EIB)-- 20,
Development of Drugs to 2002
Prevent EIB
------------------------------------------------------------------------
Female Sexual Dysfunction: May 19, Do. Do. Do.
Clinical Development of 2000
Drug Products for
Treatment
------------------------------------------------------------------------
Guidance for Institutional March Do. Do. Do.
Review Boards, Clinical 2000
Investigators, and
Sponsors: Exception from
Informed Consent
Requirements for
Emergency Research
------------------------------------------------------------------------
Inhalation Drug Products July 26, Do. Do. Do.
Packaged in Semipermeable 2002
Container Closure Systems
------------------------------------------------------------------------
OTC Treatment of Herpes March 8, Do. Do. Do.
Labialis with Antiviral 2000
Agents
------------------------------------------------------------------------
Pediatric Oncology Studies June 21, Do. Do. Do.
in Response to a Written 2000
Request
------------------------------------------------------------------------
[[Page 848]]
Preclinical and Clinical April 1, Do. Do. Do.
Evaluation of Agents Used 1994
in the Prevention or
Treatment of
Postmenopausal
Osteoporosis
------------------------------------------------------------------------
Preparation of IND Septembe Do. Do. N/A
Applications for New r 1,
Drugs Intended for the 1991
Treatment of HIV-Infected
Individuals
------------------------------------------------------------------------
Recommendations for November Do. Do. http://
Complying With the 2000 www.fda.g
Pediatric Rule ov/cder/
guidance/
index.htm
------------------------------------------------------------------------
Drug Metabolism/Drug April 7, Clinical Do. Do.
Interaction Studies in 1997 pharmacol
the Drug Development ogy
Process: Studies In Vitro
------------------------------------------------------------------------
Exposure-Response April Do. Do. Do.
Relationships--Study 2003
Design, Data Analysis,
and Regulatory
Applications
------------------------------------------------------------------------
Format and Content of the February Do. Do. Do.
Human Pharmacokinetics 1, 1987
and Bioavailability
Section of an Application
------------------------------------------------------------------------
In Vivo Metabolism/Drug November Do. Do. Do.
Interaction Studies-- 24,
Study Design, Data 1999
Analysis, and
Recommendations for
Dosing and Labeling
------------------------------------------------------------------------
Pharmacokinetics in May 30, Do. Do. Do.
Patients With Impaired 2003
Hepatic Function; Study
Design, Data Analysis,
and Impact on Dosing and
Labeling
------------------------------------------------------------------------
Pharmacokinetics in May 1998 Do. Do. Do.
Patients with Impaired
Renal Function--Study
Design, Data Analysis,
and Impact on Dosing and
Labeling
------------------------------------------------------------------------
Population February Do. Do. Do.
Pharmacokinetics 10,
1999
------------------------------------------------------------------------
General Considerations for November Clinical Do. Do.
Pediatric Pharmacokinetic 30, pharmacol
Studies for Drugs and 1998 ogy draft
Biological Products
------------------------------------------------------------------------
A Review of FDA's May 1990 Compliance Do. Do.
Implementation of the
Drug Export Amendments of
1986
------------------------------------------------------------------------
Compressed Medical Gases February Do. Do. Do.
1989
------------------------------------------------------------------------
Computerized Systems Used April Do. Do. Do.
in Clinical Trials 1999
------------------------------------------------------------------------
Expiration Dating and June 27, Do. Do. Do.
Stability Testing of 1997
Solid Oral Dosage Form
Drugs Containing Iron
------------------------------------------------------------------------
General Principles of May 1987 Do. Do. Do.
Process Validation
------------------------------------------------------------------------
Good Laboratory Practice June Do. Do. Do.
Regulations Questions and 1981
Answers
------------------------------------------------------------------------
Guidance for Hospitals, March Do. Do. Do.
Nursing Homes, and Other 2001
Health Care Facilities--
FDA Public Health
Advisory
------------------------------------------------------------------------
Guideline for Validation December Do. Do. Do.
of Limulus Amebocyte 1987
Lysate Test as an End-
Product Endotoxin Test
for Human and Animal
Parenteral Drugs,
Biological Products, and
Medical Devices
------------------------------------------------------------------------
Monitoring of Clinical January Do. Do. Do.
Investigations 1988
------------------------------------------------------------------------
Nuclear Pharmacy Guideline May 1984 Do. Do. Do.
Criteria for Determining
When to Register as a
Drug Establishment
------------------------------------------------------------------------
Pharmacy Compounding: May 2002 Do. Do. Do.
Compliance Policy Guide
------------------------------------------------------------------------
[[Page 849]]
Possible Dioxin/PCB August Do. Do. Do.
Contamination of Drug and 23,
Biological Products 1999
------------------------------------------------------------------------
Sterile Drug Products June Do. Do. Do.
Produced by Aseptic 1987
Processing
------------------------------------------------------------------------
Street Drug Alternatives March Do. Do. Do.
2000
------------------------------------------------------------------------
Current Good Manufacturing May 6, Compliance Do. Do.
Practices for Medical 2003 draft
Gases
------------------------------------------------------------------------
Good Manufacturing April 1, Do. Do. Do.
Practice for Positron 2002
Emission Tomography Drug
Products
------------------------------------------------------------------------
Guidance for IRBs, May 12, Do. Do. Do.
Clinical Investigators, 2000
and Sponsors: Exception
from Informed Consent
Requirements for
Emergency Research
------------------------------------------------------------------------
Investigating Out of Septembe Do. Do. Do.
Specification (OOS) Test r 30,
Results for 1998
Pharmaceutical Production
------------------------------------------------------------------------
Manufacture, Processing, April Do. Do. Do.
or Holding of Active 17,
Pharmaceutical 1998
Ingredients
------------------------------------------------------------------------
Marketed Unapproved Drugs-- October Do. .......... Do.
Compliance Policy Guide 2003
------------------------------------------------------------------------
Prescription Drug June 27, Do. Do. Do.
Marketing Act Regulations 2002
for Donation of
Prescription Drug Samples
to Free Clinics
------------------------------------------------------------------------
Repackaging of Solid Oral February Do. Do. N/A
Dosage Form Drug Products 1, 1992
------------------------------------------------------------------------
Part 11, Electronic August Current Do. http://
Records; Electronic 2003 good www.fda.g
Signatures--Scope and manufactu ov/cder/
Application ring guidance/
practices index.htm
(CGMPs)
------------------------------------------------------------------------
Comparability Protocols-- Septembe CGMPs Do. Do.
Protein Drug Products and r 2003 draft
Biological Products--
Chemistry, Manufacturing,
and Controls Information
------------------------------------------------------------------------
Formal Dispute Resolution: August Do. Do. Do.
Scientific and Technical 2003
Issues Related to
Pharmaceutical Current
Good Manufacturing
Practices
------------------------------------------------------------------------
Powder Blends and Finished November Do. Do. Do.
Dosage Units--Stratified 7, 2003
In-Process Dosage Unit
Sampling and Assessment
------------------------------------------------------------------------
Process Analytical October Do. Do. Do.
Technology--A Framework 4, 2004
for Innovative
Pharmaceutical
Manufacturing and Quality
Assurance
------------------------------------------------------------------------
Sterile Drug Products October Do. Do. Do.
Produced by Aseptic 4, 2004
Processing
------------------------------------------------------------------------
Providing Electronic June 27, Electronic Do. Do.
Submissions in Electronic 2002 submissio
Format--ANDAs ns
------------------------------------------------------------------------
Regulatory Submissions in January Do. Do. Do.
Electronic Format; 28,
General Considerations 1999
------------------------------------------------------------------------
Regulatory Submissions in January Do. Do. Do.
Electronic Format; New 28,
Drug Applications 1999
------------------------------------------------------------------------
Providing Regulatory August Electronic Do. Do.
Submissions in Electronic 2003 submissio
Format--Annual Reports ns draft
for NDAs and ANDAs
------------------------------------------------------------------------
[[Page 850]]
Providing Regulatory February Do. Do. Do.
Submissions in Electronic 2004
Format--Content of
Labeling
------------------------------------------------------------------------
Providing Regulatory October Do. Do. Do.
Submissions in Electronic 22,
Format--General 2003
Considerations
------------------------------------------------------------------------
Providing Regulatory August Do. Do. Do.
Submissions in Electronic 29,
Format--Human 2003
Pharmaceutical Product
Applications and Related
Submissions
------------------------------------------------------------------------
Providing Regulatory May 4, Do. Do. Do.
Submissions in Electronic 2001
Format--Postmarketing
Expedited Safety Reports
------------------------------------------------------------------------
Providing Regulatory June Do. Do. Do.
Submissions in Electronic 2003
Format--Postmarketing
Periodic Adverse Drug
Experience Reports
------------------------------------------------------------------------
Providing Regulatory January Do. Do. Do.
Submissions in Electronic 31,
Format, Prescription Drug 2001
Advertising and
Promotional Labeling
------------------------------------------------------------------------
180-Day Exclusivity When July Generics Do.
Multiple Abbreviated New 2003
Drug Applications Are
Submitted on the Same Day
------------------------------------------------------------------------
Alternate Source of Active December Do. Do. Do.
Pharmaceutical 12,
Ingredients in Pending 2000
ANDAs
------------------------------------------------------------------------
ANDAs: Impurities in Drug November Do. Do. Do.
Substances 1999
------------------------------------------------------------------------
Court Decisions, ANDA March Do. Do. Do.
Approvals, and 180-Day 2000
Exclusivity Under the
Hatch-Waxman Amendments
to the Federal Food,
Drug, and Cosmetic Act
------------------------------------------------------------------------
Letter announcing that the August Do. Do. Do.
OGD will now accept the 1995
ICH long-term storage
conditions as well as the
stability studies
conducted in the past
------------------------------------------------------------------------
Letter describing efforts October Do. Do. Do.
by the CDER & the ORA to 1994
clarify the
responsibilities of CDER
chemistry review
scientists and ORA field
investigators in the new
& abbreviated drug
approval process in order
to reduce duplication or
redundancy in the process
------------------------------------------------------------------------
Letter on incomplete April Do. Do. Do.
Abbreviated Applications, 1994
Convictions Under GDEA,
Multiple Supplements,
Annual Reports for Bulk
Antibiotics, Batch Size
for Transdermal Drugs,
Bioequivalence Protocols,
Research, Deviations from
OGD Policy
------------------------------------------------------------------------
Letter on the provision of July Do. Do. Do.
new information 1992
pertaining to new
bioequivalence guidelines
and refuse-to-file
letters
------------------------------------------------------------------------
Letter on the provision of March Do. Do. Do.
new procedures and 1989
policies affecting the
generic drug review
process
------------------------------------------------------------------------
Letter on the request for November Do. Do. Do.
cooperation of regulated 1991
industry to improve the
efficiency and
effectiveness of the
generic drug review
process, by assuring the
completeness and accuracy
of required information
and data submissions
------------------------------------------------------------------------
Letter on the response to March Do. Do. Do.
12/20/84 letter from the 1985
Pharmaceutical
Manufacturers Association
about the Drug Price
Competition and Patent
Term Restoration Act
------------------------------------------------------------------------
[[Page 851]]
Letter to all ANDA and January Do. Do. Do.
AADA applicants about the 1993
Generic Drug Enforcement
Act of 1992 (GDEA), and
the Office of Generic
Drugs intention to refuse-
to-file incomplete
submissions as required
by the new law
------------------------------------------------------------------------
Letter to regulated August Do. Do. Do.
industry notifying 1993
interested parties about
important detailed
information regarding
labeling, scale-up,
packaging, minor/major
amendment criteria, and
bioequivalence
requirements
------------------------------------------------------------------------
Major, Minor, and December Do. Do. Do.
Telephone Amendments to 2001
Abbreviated New Drug
Applications
------------------------------------------------------------------------
Organization of an ANDA March 2, Do. Do. Do.
1999
------------------------------------------------------------------------
Revising ANDA Labeling May 2000 Do. Do. Do.
Following Revision of the
RLD Labeling
------------------------------------------------------------------------
Skin Irritation and February Do. Do. Do.
Sensitization Testing of 3, 2000
Generic Transdermal Drug
Products
------------------------------------------------------------------------
Variations in Drug December Do. Do. Do.
Products that May Be 1998
Included in a Single ANDA
------------------------------------------------------------------------
ANDAs: Impurities in Drug January Generics Do. Do.
Products 5, 1999 draft
------------------------------------------------------------------------
Handling and Retention of May 26, Do. Do. Do.
Bioavailability and 2004
Bioequivalence Testing
Samples
------------------------------------------------------------------------
Potassium Chloride August Do. Do. Do.
Modified-Release Tablets 7, 2002
and Capsules: In Vivo
Bioequivalence and In
Vitro Dissolution Testing
(revised)
------------------------------------------------------------------------
Pharmacology/Toxicology May 2001 Good Do. Do.
Review Format review
practices
(GRP)
------------------------------------------------------------------------
Conducting a Clinical November GRP draft Do. Do.
Safety Review of a New 22,
Product Application and 1996
Preparing a Report on the
Review
------------------------------------------------------------------------
Good Review Management July 28, Do. Do. Do.
Principles for 2003
Prescription Drug User
Fee Act Products
------------------------------------------------------------------------
E10--Choice of Control May 14, ICH, Do. Do.
Group and Related Issues 2001 efficacy
in Clinical Trials
------------------------------------------------------------------------
E11--Clinical December Do. Do. Do.
Investigation of 15,
Medicinal Products in the 2000
Pediatric Population
------------------------------------------------------------------------
E1A--The Extent of March Do. Do. Do.
Population Exposure to 1995
Assess Clinical Safety:
for Drugs Intended for
Long-Term Treatment of
Non-Life-Threatening
Conditions
------------------------------------------------------------------------
E2A--Clinical Safety Data March Do. Do. Do.
Management: Definitions 1995
and Standards for
Expedited Reporting
------------------------------------------------------------------------
E2B--Data Elements for January Do. Do. Do.
Transmission of 15,
Individual Case Safety 1998
Reports
------------------------------------------------------------------------
E2BM--Data Elements for April 3, Do. Do. Do.
Transmission of 2002
Individual Case Safety
Reports (revised)
------------------------------------------------------------------------
E2BM--Data Elements for May 2004 Do. Do. Do.
Transmission of
Individual Case Safety
Reports--Questions and
Answers
------------------------------------------------------------------------
E2C--Clinical Safety Data May 19, Do. Do. Do.
Management: Periodic 1997
Safety Update Reports for
Marketed Drugs
------------------------------------------------------------------------
[[Page 852]]
E2C Addendum--Clinical February Do. Do. Do.
Safety Data Management: 5, 2004
Periodic Safety Update
Reports for Marketed
Drugs
------------------------------------------------------------------------
E3--Structure and Content July Do. Do. Do.
of Clinical Study Reports 1996
------------------------------------------------------------------------
E4--Dose-Response November Do. Do. Do.
Information to Support 1994
Drug Registration
------------------------------------------------------------------------
E5--Ethnic Factors in the June Do. Do. Do.
Acceptability of Foreign 1998
Clinical Data
------------------------------------------------------------------------
E6--Good Clinical May 9, Do. Do. Do.
Practice: Consolidated 1997
Guideline
------------------------------------------------------------------------
E7--Studies in Support of August Do. Do. Do.
Special Populations: 1994
Geriatrics
------------------------------------------------------------------------
E8--General Considerations December Do. Do. Do.
for Clinical Trials 24,
1997
------------------------------------------------------------------------
E9--Statistical Principles Septembe Do. Do. Do.
for Clinical Trials r 1998
------------------------------------------------------------------------
M2 eCTD: Electronic Common April 2, ICH, joint Do. Do.
Technical Document 2003 safety/
Specification efficacy
(multidis
ciplinary
)
------------------------------------------------------------------------
M3--Nonclinical Safety November Do. Do. Do.
Studies for the Conduct 25,
of Human Clinical Trials 1997
for Pharmaceuticals
------------------------------------------------------------------------
M4--Organization of the August Do. Do. Do.
CTD 2004
------------------------------------------------------------------------
M4--The CTD--Efficacy May 2004 Do. Do. Do.
Questions and Answers
------------------------------------------------------------------------
M4--The CTD--General May 2004 Do. Do. Do.
Questions and Answers
------------------------------------------------------------------------
M4--The CTD--Safety February Do. Do. Do.
Questions and Answers 4, 2003
------------------------------------------------------------------------
Q1A(R2)--Stability Testing November ICH, Do. Do.
of New Drug Substances 21, quality
and Products 2003
------------------------------------------------------------------------
Q1B--Photostability November Do. Do. Do.
Testing of New Drug 1996
Substances and Products
------------------------------------------------------------------------
Q1C--Stability Testing for May 9, Do. Do. Do.
New Dosage Forms 1997
------------------------------------------------------------------------
Q1D--Bracketing and January Do. Do. Do.
Matrixing Designs for 16,
Stability Testing of New 2003
Drug Substances and
Products
------------------------------------------------------------------------
Q1F--Stability Data June Do. Do. Do.
Package for the 2004
Registration in Climatic
Zones III and IV
------------------------------------------------------------------------
Q2A--Text on Validation of March Do. Do. Do.
Analytical Procedures 1995
------------------------------------------------------------------------
Q2B--Validation of May 19, Do. Do. Do.
Analytical Procedures: 1997
Methodology
------------------------------------------------------------------------
Q3A--Impurities in New February Do. Do. Do.
Drug Substances 2003
------------------------------------------------------------------------
Q3B(R)--Impurities in Drug November Do. Do. Do.
Products 14,
2003
------------------------------------------------------------------------
Q3C--Impurities: Residual December Do. Do. Do.
Solvents 24,
1997
------------------------------------------------------------------------
Q3C--Tables and List November Do. Do. Do.
(revised recommendations 2003
for N-Methylpyrrolidone
and Tetrahydrofuran)
------------------------------------------------------------------------
Q5A--Viral Safety Septembe Do. Do. Do.
Evaluation of r 24,
Biotechnology Products 1998
Derived From Cell Lines
of Human or Animal Origin
------------------------------------------------------------------------
[[Page 853]]
Q5B--Quality of February Do. Do. Do.
Biotechnology Products: 1996
Analysis of the
Expression Construct in
Cells Used for Production
of r-DNA Derived Protein
Products
------------------------------------------------------------------------
Q5C--Quality of July Do. Do. Do.
Biotechnological 1996
Products: Stability
Testing of Biotechnology/
Biological Products
------------------------------------------------------------------------
Q5D--Quality of Septembe Do. Do. Do.
Biotechnological/ r 21,
Biological Products: 1998
Derivation and
Characterization of Cell
Substrates Used for
Production of
Biotechnological/
Biological Products
------------------------------------------------------------------------
Q6A--Specifications: Test December Do. Do. Do.
Procedures and Acceptance 29,
Criteria for New Drug 2000
Substances and New Drug
Products: Chemical
Substances
------------------------------------------------------------------------
Q6B--Test Procedures and August Do. Do. Do.
Acceptance Criteria for 18,
Biotechnological/ 1999
Biological Products
------------------------------------------------------------------------
Q7A--Good Manufacturing August Do. Do. Do.
Practice for Active 2001
Pharmaceutical
Ingredients
------------------------------------------------------------------------
S1A--The Need for Long- March ICH, Do. Do.
Term Rodent 1996 safety
Carcinogenicity Studies
of Pharmaceuticals
------------------------------------------------------------------------
S1B--Testing for July Do. Do. Do.
Carcinogenicity of 1997
Pharmaceuticals
------------------------------------------------------------------------
S1C--Dose Selection for March Do. Do. Do.
Carcinogenicity Studies 1995
of Pharmaceuticals
------------------------------------------------------------------------
S1C(R)--Dose Selection for December Do. Do. Do.
Carcinogenicity Studies 4, 1997
of Pharmaceuticals:
Addendum on a Limit Dose
and Related Notes
------------------------------------------------------------------------
S2A--Specific Aspects of April Do. Do. Do.
Regulatory Genotoxicity 1996
Tests for Pharmaceuticals
------------------------------------------------------------------------
S2B--Genotoxicity: A November Do. Do. Do.
Standard Battery for 21,
Genotoxicity Testing of 1997
Pharmaceuticals
------------------------------------------------------------------------
S3A--Toxicokinetics: The March Do. Do. Do.
Assessment of Systemic 1995
Exposure in Toxicity
Studies
------------------------------------------------------------------------
S3B--Pharmacokinetics: March Do. Do. Do.
Repeated Dose Tissue 1995
Distribution Studies
------------------------------------------------------------------------
S4A--Duration of Chronic June 25, Do. Do. Do.
Toxicity Testing in 1999
Animals (Rodent and
Nonrodent Toxicity
Testing)
------------------------------------------------------------------------
S5A--Detection of Toxicity Septembe Do. Do. Do.
to Reproduction for r 22,
Medicinal Products 1994
------------------------------------------------------------------------
S5B--Detection of Toxicity April Do. Do. Do.
to Reproduction for 1996
Medicinal Products:
Addendum on Toxicity to
Male Fertility
------------------------------------------------------------------------
S6--Preclinical Safety November Do. Do. Do.
Evaluation of 18,
Biotechnology-Derived 1997
Pharmaceuticals
------------------------------------------------------------------------
S7A--Safety Pharmacology July 13, Do. Do. Do.
Studies for Human 2001
Pharmaceuticals
------------------------------------------------------------------------
E2D--Postapproval Safety July ICH draft, Do. Do.
Data Management: 2003 efficacy
Definitions and Standards
for Expedited Reporting
------------------------------------------------------------------------
E12A--Principles for August Do. Do. Do.
Clinical Evaluation of 9, 2000
New Antihypertensive
Drugs
------------------------------------------------------------------------
[[Page 854]]
M4--Common Technical December ICH draft, Do. Do.
Document--Quality: 30, joint
Questions and Answers/ 2002 safety/
Location Issues efficacy
(multidis
ciplinary
)
------------------------------------------------------------------------
Submitting Marketing Septembe Do. Do. Do.
Appilcations According to r 5,
the ICH-CTD Format-- 2001
General Considerations
------------------------------------------------------------------------
Q1E--Evaluation of June 14, ICH draft, Do. Do.
Stability Data 2002 quality
------------------------------------------------------------------------
S7B--The Nonclinical June ICH draft, Do. Do.
Evaluation of the 2004 safety
Potential for Delayed
Ventricular
Repolarization (QT
Interval Prolongation) by
Human Pharmaceuticals
------------------------------------------------------------------------
Content and Format of INDs November IND Do. Do.
for Phase 1 Studies of 1995
Drugs; Including Well-
Characterized,
Therapeutic,
Biotechnology-Derived
Products
------------------------------------------------------------------------
A Revision in Sample July 15, Industry Do. N/A
Collection Under the 1996 letters
Compliance Program
Pertaining to Preapproval
Inspections
------------------------------------------------------------------------
Continuation of a series March 2, Do. Do. http://
of letters communicating 1998 www.fda.g
interim and informal ov/cder/
generic drug policy and guidance/
guidance. Availability of index.htm
Policy and Procedure
Guides, and further
operational changes to
the generic drug review
program
------------------------------------------------------------------------
Fifth of a series of April Do. Do. Do.
letters providing 1987
informal notice about the
Act, discussing the
statutory mechanism by
which ANDA applicants may
make modifications in
approved drugs where
clinical data is required
------------------------------------------------------------------------
Fourth of a series of October Do. Do. Do.
letters providing 1986
informal notice to all
affected parties about
policy developments and
interpretations regarding
the Act. Three year
exclusivity provisions of
Title I
------------------------------------------------------------------------
Implementation of the Drug October Do. Do. Do.
Price Competition and 1984
Patent Term Restoration
Act. Preliminary Guidance
------------------------------------------------------------------------
Implementation Plan USP October Do. Do. Do.
injection nomenclature 1995
------------------------------------------------------------------------
Instructions for Filing April Do. Do. N/A
Supplements Under the 11,
Provisions of SUPAC-IR 1996
------------------------------------------------------------------------
Seventh of a series of July Do. Do. http://
letters about the Act 1988 www.fda.g
providing guidance on the ov/cder/
``180-day exclusivity'' guidance/
provision of section index.htm
505(j)(4)(B)(iv) of the
FD&C Act
------------------------------------------------------------------------
Sixth of a series of April Do. Do. Do.
informal notice letters 1988
about the Act discussing
3- and 5-year exclusivity
provisions of sections
505(c)(3)(D) and
505(j)(4)(D) of the FD&C
Act
------------------------------------------------------------------------
Streamlining Initiatives December Do. Do. N/A
24,
1996
------------------------------------------------------------------------
Supplement to 10/11/84 November Do. Do. http://
letter about policies, 1984 www.fda.g
procedures and ov/cder/
implementation of the Act guidance/
(Q & A format) index.htm
------------------------------------------------------------------------
Third of a series of May 1985 Do. Do. Do.
letters regarding the
implementation of the Act
------------------------------------------------------------------------
Year 2000 Letter from Dr. October Do. Do. Do.
Janet Woodcock 19,
1998
------------------------------------------------------------------------
Barbiturate, Single Entity- March 1, Labeling Do. N/A
Class Labeling 1981
------------------------------------------------------------------------
[[Page 855]]
Content and Format for October Do. Do. http://
Geriatric Labeling 5, 2001 www.fda.g
ov/cder/
guidance/
index.htm
------------------------------------------------------------------------
Hypoglycemic Oral Agents April 1, Do. Do. N/A
1984
------------------------------------------------------------------------
Labeling Over-the-Counter October Do. Do. http://
Human Drug Products; 18, www.fda.g
Updating Labeling in 2002 ov/cder/
Reference Listed Drugs guidance/
and Abbreviated New Drug index.htm
Applications
------------------------------------------------------------------------
Local Anesthetics--Class Septembe Do. Do. N/A
Labeling r 1,
1982
------------------------------------------------------------------------
Clinical Studies Section July 9, Labeling Do. http://
of Labeling for 2001 draft www.fda.g
Prescription Drugs and ov/cder/
Biologics--Content and guidance/
Format index.htm
------------------------------------------------------------------------
Content and Format of the March 5, Do. Do. Do.
Adverse Reactions Section 2004
of Labeling for Human
Prescription Drugs and
Biologics
------------------------------------------------------------------------
Labeling for Combined Oral March Do. Do. Do.
Contraceptives 2004
------------------------------------------------------------------------
Labeling for February Do. Do. Do.
Noncontraceptive Estrogen 2004
Drug Products for the
Treatment of Vasomotor
Symptoms and Vulvar and
Vaginal Atrophy Symptoms--
Prescribing Information
for Health Care Providers
and Patient Labeling
------------------------------------------------------------------------
OTC Topical Drug Products June Do. Do. Do.
for the Treatment of 1998
Vaginal Yeast Infections
(Vulvovaginal
Candidiasis)
------------------------------------------------------------------------
Referencing Discontinued October Do. Do. Do.
Labeling for Listed Drugs 26,
in Abbreviated New Drug 2000
Applications
------------------------------------------------------------------------
Enforcement Policy on May 1984 OTC Do. Do.
Marketing OTC Combination
Products (CPG 7132b.16)
------------------------------------------------------------------------
General Guidelines for OTC Septembe Do. Do. Do.
Combination Products r 1978
------------------------------------------------------------------------
Labeling OTC Human Drug December Do. Do. Do.
Products Using a Column 19,
Format 2000
------------------------------------------------------------------------
Upgrading Category III October Do. Do. Do.
Antiperspirants to 1978
Category I (43 FR 46728-
46731)
------------------------------------------------------------------------
Labeling OTC Human Drug December OTC draft Do. Do.
Products--Submitting 19,
Requests for Exemptions 2000
and Deferrals
------------------------------------------------------------------------
Labeling OTC Human Drug February Do. Do. Do.
Products Updating 2001
Labeling in ANDAs
------------------------------------------------------------------------
OTC Actual Use Studies July 22, Do. Do. N/A
1994
------------------------------------------------------------------------
OTC Nicotine Substitutes March 1, Do. Do. Do.
1994
------------------------------------------------------------------------
Time and Extent February Do. Do. http://
Applications 10, www.fda.g
2004 ov/cder/
guidance/
index.htm
------------------------------------------------------------------------
Carcinogenicity Study May 2002 Pharmacolo Do. Do.
Protocol Submissions gy/
Toxicolog
y
------------------------------------------------------------------------
Format and Content of the February Do. Do. Do.
Nonclinical Pharmacology/ 1987
Toxicology Section of an
Application
------------------------------------------------------------------------
Immunotoxicology October Do. Do. Do.
Evaluation of 2002
Investigational New Drugs
------------------------------------------------------------------------
[[Page 856]]
Nonclinical Pharmacology/ October Do. Do. Do.
Toxicology Development of 1996
Topical Drugs Intended to
Prevent the Transmission
of Sexually Transmitted
Diseases (STD) and/or for
the Development of Drugs
Intended to Act as
Vaginal Contraceptives
------------------------------------------------------------------------
Photosafety Testing May 7, Do. Do. Do.
2003
------------------------------------------------------------------------
Reference Guide for the February Do. Do. Do.
Nonclinical Toxicity 1989
Studies of Antiviral
Drugs Indicated for the
Treatment of N/A Non-Life
Threatening Disease:
Evaluation of Drug
Toxicity Prior to Phase I
Clinical Studies
------------------------------------------------------------------------
Single Dose Acute Toxicity August Do. Do. Do.
Testing for 1996
Pharmaceuticals
------------------------------------------------------------------------
Estimating the Safe January Pharmacolo Do. Do.
Starting Dose in Clinical 16, gy/
Trials for Therapeutics 2003 Toxicolog
in Adult Healthy y draft
Volunteers
------------------------------------------------------------------------
Integration of Study November Do. Do. Do.
Results to Access 13,
Concerns About Human 2001
Reproductive and
Developmental Toxicities
------------------------------------------------------------------------
Nonclinical Safety February Do. Do. Do.
Evaluation of Pediatric 2003
Drug Products
------------------------------------------------------------------------
Nonclinical Studies for October Do. Do. Do.
Development of 2, 2002
Pharmaceutical Excipients
------------------------------------------------------------------------
Statistical Aspects of the May 8, Do. Do. Do.
Design, Analysis, and 2001
Interpretation of Chronic
Rodent Carcinogenicity
Studies of
Pharmaceuticals
------------------------------------------------------------------------
180-Day Generic Drug June Procedural Do. Do.
Exclusivity Under the 1998
Hatch-Waxman Amendments
to the Federal Food,
Drug, and Cosmetic Act
------------------------------------------------------------------------
Continuous Marketing October Do. Do. Do.
Applications: Pilot 1-- 2003
Reviewable Units for Fast
Track Products Under the
PDUFA
------------------------------------------------------------------------
Continuous Marketing October Do. Do. Do.
Applications: Pilot 2-- 2003
Scientific Feedback and
Interactions During Drug
Development of Fast Track
Products Under the PDUFA
------------------------------------------------------------------------
Court Decisions, ANDA March Do. Do. Do.
Approvals, and 180-Day 27,
Exclusivity Under the 2000
Hatch-Waxman Amendments
to the Federal Food,
Drug, and Cosmetic Act
------------------------------------------------------------------------
Disclosure of Materials November Do. Do. Do.
Provided to Advisory 30,
Committees in Connection 1999
with Open Advisory
Committee Meetings
Convened by the Center
for Drug Evaluation and
Research Beginning on
January 1, 2000
------------------------------------------------------------------------
Drug Products Containing June 3, Do. Do. Do.
Ensulizole, Hypromellose, 2003
Meradimate, Octinoxate,
and Octisalate--Labeling
Enforcement Policy
------------------------------------------------------------------------
Enforcement Policy During November Do. Do. Do.
Implementation of Section 23,
503A of the Federal Food, 1998
Drug, and Cosmetic Act
------------------------------------------------------------------------
Fast Track Drug July Do. Do. Do.
Development Programs-- 2004
Designation, Development,
and Application Review
------------------------------------------------------------------------
Financial Disclosure by March Do. Do. Do.
Clinical Investigators 2001
------------------------------------------------------------------------
Formal Dispute Resolution: February Do. Do. Do.
Appeals Above the 2000
Division Level
------------------------------------------------------------------------
[[Page 857]]
Formal Meetings With February Do. Do. Do.
Sponsors and Applicants 2003
For PDUFA Products
------------------------------------------------------------------------
Implementation of Section November Do. Do. Do.
120 of the Food and Drug 2, 1998
Administration
Modernization Act of
1997--Advisory Committees
------------------------------------------------------------------------
Implementation of Section July 21, Do. Do. Do.
126 of the Food and Drug 1998
Administration
Modernization Act of
1997--Elimination of
Certain Labeling
Requirements
------------------------------------------------------------------------
Information Program on January Do. Do. Do.
Clinical Trials for 27,
Serious or Life- 2004
Threatening Diseases and
Conditions
------------------------------------------------------------------------
Potassium Iodide in December Do. Do. Do.
Radiation Emergencies-- 23,
Questions and Answers 2002
------------------------------------------------------------------------
Potassium Iodide Tablets March 8, Do. Do. Do.
for Shelf Life Extension 2004
for Federal Agencies and
State and Local
Governments
------------------------------------------------------------------------
Levothyroxine Sodium July 13, Do. Do. Do.
Products Enforcement of 2001
August 14, 2001,
Compliance Date and
Submission of New
Applications
------------------------------------------------------------------------
National Uniformity for April 9, Do. Do. Do.
Nonprescription Drugs-- 1998
Ingredient Listing for
OTC Drugs
------------------------------------------------------------------------
Potassium Iodide as a December Do. Do. Do.
Thyroid Blocking Agent in 11,
Radiation Emergencies 2001
------------------------------------------------------------------------
Qualifying for Pediatric Septembe Do. Do. Do.
Exclusivity Under Section r 1999
505A of the Federal Food,
Drug, and Cosmetic Act
(revised)
------------------------------------------------------------------------
Refusal to File July 12, Do. Do. Do.
1993
------------------------------------------------------------------------
Repeal of Section 507 of May 1998 Do. Do. Do.
the Federal Food, Drug,
and Cosmetic Act
------------------------------------------------------------------------
Special Protocol May 17, Do. Do. Do.
Assessment 2002
------------------------------------------------------------------------
Standards for the Prompt May 15, Do. Do. Do.
Review of Efficacy 1998
Supplements, Including
Priority Efficacy
Supplements
------------------------------------------------------------------------
Guidance for FDA Staff: June 19, Do. Do. Do.
The Leveraging Handbook; 2003
an Agency Resource for
Effective Collaborations
------------------------------------------------------------------------
Women and Minorities July 20, Do. Do. Do.
Guidance Requirements 1998
------------------------------------------------------------------------
Applications Covered by October Procedural Do. Do.
Section 505(b)(2) 1999 draft
------------------------------------------------------------------------
Clinical Trial Sponsors On November Do. Do. Do.
the Establishment and 2001
Operation of Clinical
Trial Data Monitoring
Committees
------------------------------------------------------------------------
PET Drug Applications-- March Do. Do. Do.
Content and Format for 2000
NDAs and ANDAs
------------------------------------------------------------------------
Disclosing Information December Do. Do. Do.
Provided to Advisory 22,
Committees in Connection 1999
with Open Advisory
Committee Meetings
Related to the Testing or
Approval of New Drugs and
Convened by CDER,
Beginning January 1, 2000
------------------------------------------------------------------------
Disclosure of Conflicts of February Do. Do. Do.
Interest for Special 14,
Government Employees 2002
Participating in FDA
Product Specific Advisory
Committees
------------------------------------------------------------------------
[[Page 858]]
Forms for Registration of April Do. Do. Do.
Producers of Drugs and 2001
Listing of Drugs in
Commercial Distribution
------------------------------------------------------------------------
Good Review Management July 28, Do. Do. Do.
Principles for PDUFA 2003
Products
------------------------------------------------------------------------
Independent Consultants May 7, Do. Do. Do.
for Biotechnology 2003
Clinical Trial Protocols
------------------------------------------------------------------------
Information Program on January Do. Do. Do.
Clinical Trials for 27,
Serious or Life- 2004
Threatening Diseases and
Conditions
------------------------------------------------------------------------
Pharmacogenomic Data January Do. Do. Do.
Submissions 27,
2004
------------------------------------------------------------------------
Postmarketing Safety March Do. Do. Do.
Reporting for Human Drug 12,
and Biological Products 2001
Including Vaccines
------------------------------------------------------------------------
Reports on the Status of April 4, Do. Do. Do.
Postmarketing Studies-- 2001
Implementation of Section
130 of the Food and Drug
Administration
Modernization Act of 1997
------------------------------------------------------------------------
Submitting Debarment October Do. Do. Do.
Certification Statements 2, 1998
------------------------------------------------------------------------
Submitting Marketing Septembe Do. Do. Do.
Applications According to r 5,
the ICH/CTD Format-- 2001
General Considerations
------------------------------------------------------------------------
The Use of Clinical Holds April Do. Do. Do.
Following Clinical 2002
Investigator Misconduct
------------------------------------------------------------------------
Sterility Requirements for November Small Do. Do.
Aqueous-Based Drug 7, 2001 entity
Products for Oral complianc
Inhalation--Small Entity e guides
Compliance Guide
------------------------------------------------------------------------
Applicability of User Fees July 12, User fee Do. Do.
to (1) Applications 1993
Withdrawn Before Filing,
or (2) Applications the
Agency Has Refused to
File and That Are
Resubmitted or Filed Over
Protest (Attachment F)
------------------------------------------------------------------------
Application, Product, and December Do. Do. Do.
Establishment Fees: 16,
Common Issues and Their 1994
Resolution (revised)
(attachment D) (I)
------------------------------------------------------------------------
Classifying Resubmissions May 14, Do. Do. Do.
in Response to Action 1998
Letters
------------------------------------------------------------------------
Fees-Exceed-the-Costs June Do. Do. Do.
Waivers Under the 1999
Prescription Drug User
Fee Act
------------------------------------------------------------------------
Information Request and November Do. Do. Do.
Discipline Review Letters 21,
Under the Prescription 2001
Drug User Fee Act
------------------------------------------------------------------------
Submitting and Reviewing October Do. Do. Do.
Complete Responses to 26,
Clinical Holds (revised) 2000
------------------------------------------------------------------------
Document for Waivers of July 16, User fees Do. Do.
and Reductions in User 1993 draft
Fees (attachment G)
------------------------------------------------------------------------
Submitting Separate December Do. Do. Do.
Marketing Applications 2000
and Clinical Data for
Purposes of Assessing
User Fees
¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤
WITHDRAWALS
------------------------------------------------------------------------
In Vivo Bioequivalence December Do. Do.
Studies on Population and 30,
Individual Bioequivalence 1987
Studies
------------------------------------------------------------------------
Clinical Evaluation of April 1, N/A N/A
Antacid Drugs 1978
------------------------------------------------------------------------
Clinical Evaluation of Septembe Do. Do.
Antidiarrheal Drugs r 1,
1977
------------------------------------------------------------------------
[[Page 859]]
Clinical Evaluation of Septembe Do. Do.
Gastric Secretory r 1,
Depressant (GSD) Drugs 1977
------------------------------------------------------------------------
Clinical Evaluation of April 1, Do. Do.
Laxative Drugs 1978
------------------------------------------------------------------------
Clinical Evaluation of October Do. Do.
Radiopharmaceutical Drugs 1, 1981
------------------------------------------------------------------------
FDA Requirements for June 20, Do. Do.
Approval of Drugs to 1989
Treat Superficial Bladder
Cancer
------------------------------------------------------------------------
ANDAs: Blend Uniformity August Do. Do.
Analysis 27,
1999
------------------------------------------------------------------------
Topical Dermatological June 18, Do. Do.
Drug Products NDAs and 1998
ANDAs--In Vivo
Bioavailability,
Bioequivalence, In Vitro
Release, and Associated
Studies
------------------------------------------------------------------------
Clinical Evaluation of March 1, Do. Do.
Combination Estrogen/ 1995
Progestin-Containing Drug
Products Used for Hormone
Replacement Therapy of
Postmenopausal Women
------------------------------------------------------------------------
Noncontraceptive Estrogen Septembe Do. Do.
Drug Products-- r 27,
Prescribing Information 1999
for Healthcare Providers
and Patient Labeling
------------------------------------------------------------------------
Chlordiazepoxide January Do. Do.
Hydrochloride Capsules 1, 1988
------------------------------------------------------------------------
Clorazepate Dipotassium March 1, Do. Do.
Capsules/Tablets 1993
------------------------------------------------------------------------
Cyproheptadine December Do. Do.
Hydrochloride Tablets/ 1, 1986
Syrup
------------------------------------------------------------------------
Dipivefrin Hydrochloride November Do. Do.
Ophthalmic Solution, 0.1% 2, 1998
------------------------------------------------------------------------
Ergoloid Mesylate Tablets January Do. Do.
1, 1988
------------------------------------------------------------------------
Hydroxyzine Hydrochloride December Do. Do.
Injection 1, 1989
------------------------------------------------------------------------
Isoetharine Inhalation March 1, Do. Do.
Solution 1989
------------------------------------------------------------------------
Meclofenamate Sodium July 1, Do. Do.
Capsules 1992
------------------------------------------------------------------------
Naphazoline Hydrochloride March 1, Do. Do.
Ophthalmic Solution 1989
------------------------------------------------------------------------
Niacin Tablets July 1, Do. Do.
1992
------------------------------------------------------------------------
Phendimetrazine Tartrate February Do. Do.
Capsules/Tablets and 1, 1991
Extended-Release Capsules
------------------------------------------------------------------------
Phentermine Hydrochloride August Do. Do.
Capsules/Tablets 1, 1988
------------------------------------------------------------------------
Promethazine Hydrochloride March 1, Do. Do.
Tablets 1990
------------------------------------------------------------------------
Propantheline Bromide August Do. Do.
Tablets 1, 1988
------------------------------------------------------------------------
Pyridoxine Hydrochloride June 1, Do. Do.
Injection 1984
------------------------------------------------------------------------
Quinidine Sulfate Capsules October Do. Do.
USP 1, 1995
------------------------------------------------------------------------
Sulfamethoxazole and February Do. Do.
Phenazopyridine 1, 1992
Hydrochloride Tablets
------------------------------------------------------------------------
Theophylline Immediate February Do. Do.
Release Oral Dosage Forms 1, 1995
------------------------------------------------------------------------
Thiamine Hydrochloride February Do. Do.
Injection 1, 1988
------------------------------------------------------------------------
Vitamin A Capsules February Do. Do.
1, 1992
------------------------------------------------------------------------
Part 11; Electronic November Do. Do.
Records; Electronic 12,
Signatures, Electronic 2002
Copies of Electronic
Records
------------------------------------------------------------------------
[[Page 860]]
Clinical Evaluation of December Do. Do.
Analgesic Drugs 1, 1992
------------------------------------------------------------------------
Using FDA-Approved Patient April Do. Do.
Labeling in Consumer- 23,
Directed Print 2001
Advertisements
------------------------------------------------------------------------
Guidance Documents Issued by CDRH
----------------------------------------------------------------------------------------------------------------
Date of Intended User or Regulatory How to Obtain a Copy
Name of Document Issuance Activity of the Document
----------------------------------------------------------------------------------------------------------------
Guidance for Industry, FDA Staff, and October 4, 2004 FDA, regulated industry, and Division of Small
Third Parties; Implementation of the third parties Manufacturers,
Inspection by Accredited Persons International and
Program Under the Medical Device User Consumer Assistance,
Fee and Modernization Act of 2002; 1-800-638-2041 or 301-
Accreditation Criteria 443-6597; or Facts-on-
Demand,\1\ 301-827-
0111; or Internet at
http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/
cdrh/
guidance.html
----------------------------------------------------------------------------------------------------------------
Implementation of Third Party Programs February 2, Do. Do.
Under the FDA Modernization Act of 2001
1997; Final Guidance for Staff,
Industry, and Third Parties
----------------------------------------------------------------------------------------------------------------
Mutual Recognition Agreement Between June 29, 2000 FDA and regulated industry Do.
the European Union and the United
States of America: Confidence
Building Programme: Overview and
Procedure; Medical Device Annex,
Version 7, June 29, 2000; Draft
----------------------------------------------------------------------------------------------------------------
Draft Guidance for Industry and FDA; July 30, 1999 Do. Do.
Medical Glove Guidance Manual
----------------------------------------------------------------------------------------------------------------
Guidance for Industry and FDA; April 14, 1999 Do. Do.
Regulation of Medical Devices;
Background Information for
International Officials (entire
document available on disk)
----------------------------------------------------------------------------------------------------------------
Guidance for Staff, Industry, and January 6, 1999 Do. Do.
Third Parties; Third Party Programs
Under the Sectoral Annex on Medical
Devices to the Agreement on Mutual
Recognition Between the United States
of America and the European Community
(MRA)
----------------------------------------------------------------------------------------------------------------
Medical Device Appeals and Complaints: February 1998 Do. Do.
Guidance on Dispute Resolution
----------------------------------------------------------------------------------------------------------------
Overview of FDA Modernization Act of February 19, Do. Do.
1997 Medical Device Provisions 1998
----------------------------------------------------------------------------------------------------------------
Medical Device Reporting for March 1997 Do. Do.
Manufacturers
----------------------------------------------------------------------------------------------------------------
In Vitro Diagnostic Devices: Guidance January 1997 Do. Do.
for the Preparation of 510(k)
Submissions (FDA 97-4224)
----------------------------------------------------------------------------------------------------------------
Medical Device Quality Systems Manual: April 14, 1999 Do. Do.
A Small Entity Compliance Guide
----------------------------------------------------------------------------------------------------------------
Comparison Chart: 1996 Quality System November 29, Do. Do.
Regulation vs. 1978 Good 1996
Manufacturing Practices Regulation
vs. ANSI/ISO/ASQC Q9001-1994 and ISO/
DIS 13485:1996
----------------------------------------------------------------------------------------------------------------
Premarket Notification: 510(k)-- August 1995 Do. Do.
Regulatory Requirements for Medical
Devices (FDA 95-4158)
----------------------------------------------------------------------------------------------------------------
[[Page 861]]
Labeling--Regulatory Requirements for September 1, Do. Do.
Medical Devices 1989
----------------------------------------------------------------------------------------------------------------
Impact Resistant Lenses: Questions and September 1987 Do. Do.
Answers (FDA 87-4002)
----------------------------------------------------------------------------------------------------------------
CDRH Manual for the GGP Regulations; February 9, FDA Do.
Final Guidance for FDA Staff 2001
----------------------------------------------------------------------------------------------------------------
Human Factors Principles for Medical September 1, FDA, regulated industry Do.
Device Labeling 1993
----------------------------------------------------------------------------------------------------------------
Human Factors PTC for IDE Devices January 17, Do. Do.
1997
----------------------------------------------------------------------------------------------------------------
Write It Right August 1993 Do. Do.
----------------------------------------------------------------------------------------------------------------
Do It By Design--An Introduction to December 1996 Do. Do.
Human Factors in Medical Devices
----------------------------------------------------------------------------------------------------------------
Guidance for Industry and FDA July 18, 2000 Do. Do.
Premarket and Design Control
Reviewers; Medical Device Use--
Safety: Incorporating Human Factors
Engineering into Risk Management
----------------------------------------------------------------------------------------------------------------
Guidance on Medical Device Patient April 19, 2001 Do. Do.
Labeling; Final Guidance for Industry
and FDA Reviewers
----------------------------------------------------------------------------------------------------------------
Medical Device Reporting for User April 1996 FDA and user facilities Do.
Facilities
----------------------------------------------------------------------------------------------------------------
Frequently-Asked Questions About the July 6, 2001 FDA, regulated industry, third Do.
Reprocessing and Reuse of Single-Use party, and hospital
Devices by Third-Party and Hospital reprocessors
Reprocessors; Final Guidance for
Industry and FDA Staff
----------------------------------------------------------------------------------------------------------------
Frequently-Asked Questions About the July 16, 2003 Do. Do.
Reprocessing and Reuse of Single-Use
Devices by Third-Party and Hospital
Reprocessors; Three Additional
Questions
----------------------------------------------------------------------------------------------------------------
Continuing Education Credit for March 17, 1998 FDA, accreditation bodies, and Do.
Reading/Writing Articles/Papers and mammography facilities
Presenting Courses/Lectures
(incorporated into the Policy
Guidance Help System (PGHS))
----------------------------------------------------------------------------------------------------------------
Guidance for Submission of Request for March 26, 1998 Do. Do.
Reconsideration of Adverse Decisions
on Accreditation of Mammography
Facilities Under the Mammography
Quality Standards Acts, 42 U.S.C.
263(b)/4/8, 1998 (incorporated into
PGHS)
----------------------------------------------------------------------------------------------------------------
Guidance for Review of Requests for March 26, 1998 Do. Do.
Reconsideration of Adverse Decisions
on Accreditation of Mammography
Facilities Under the Mammography
Quality Standards Act, 42 U.S.C.
263(b)/4/8, 1998 (incorporated into
PGHS)
----------------------------------------------------------------------------------------------------------------
Policy and Standard Operating April 15, 1998 Do. Do.
Procedures When Mammography
Facilities in States That Have
Accreditation Bodies Intend to Change
Accreditation Bodies (incorporated
into PGHS)
----------------------------------------------------------------------------------------------------------------
Guidance for Industry; Requalification May 28, 1998 Do. Do.
for Interpreting Physician's
Continuing Experience Requirement
(incorporated into PGHS)
----------------------------------------------------------------------------------------------------------------
Guidance; The Mammography Quality March 19, 1999 Do. Do.
Standards Act Final Regulations;
Document 1 (incorporated
into PGHS)
----------------------------------------------------------------------------------------------------------------
[[Page 862]]
Compliance Guidance; The Mammography March 23, 1999 Do. Do.
Quality Standards Act Final
Regulations Motion of Tube-Image
Receptor Assembly (incorporated into
PGHS)
----------------------------------------------------------------------------------------------------------------
Guidance for Request and Issuance of May 4, 1999 Do. Do.
Interim Notice Letters for
Mammography Facilities Under the
Mammography Quality Standards Act, 42
U.S.C. Section 263(b) (incorporated
into PGHS)
----------------------------------------------------------------------------------------------------------------
Compliance Guidance; The Mammography December 7, Do. Do.
Quality Standards Act Final 1999
Regulations Quality Assurance
Documentation (incorporated into
PGHS)
----------------------------------------------------------------------------------------------------------------
Compliance Guidance; The Mammography February 25, Do. Do.
Quality Standards Act Final 2000
Regulations; Document 2
(incorporated into PGHS)
----------------------------------------------------------------------------------------------------------------
The Mammography Quality Standards Act July 5, 2000 Do. Do.
Final Regulations Modifications to
the Policy Guidance Help System
1; Guidance for Industry and
FDA (incorporated into PGHS)
----------------------------------------------------------------------------------------------------------------
Compliance Guidance; The Mammography July 18, 2000 Do. Do.
Quality Standards Act Final
Regulations; Document 3
(incorporated into PGHS)
----------------------------------------------------------------------------------------------------------------
Compliance Guidance; Mammography November 6, Do. Do.
Facility Survey, Equipment 2000
Evaluation, and Medical Physicist
Qualification Requirements Under
MQSA; Final (incorporated into PGHS)
----------------------------------------------------------------------------------------------------------------
The Mammography Quality Standards Act January 24, Do. Do.
Final Regulations; Modifications and 2001
Additions to Policy Guidance Help
System 2; Final Guidance for
Industry and FDA (incorporated into
PGHS)
----------------------------------------------------------------------------------------------------------------
The Mammography Quality Standards Act May 23, 2001 Do. Do.
Final Regulations Modifications and
Additions to Policy Guidance Help
System 4; Guidance for
Industry and FDA (incorporated into
PGHS)
----------------------------------------------------------------------------------------------------------------
The Mammography Quality Standards Act October 5, 2001 Do. Do.
Final Regulations Modifications to
the Policy Guidance Help System Due
to the September 11, 2002, Terrorist
Attacks; Final Guidance for Industry
and FDA (incorporated into PGHS)
----------------------------------------------------------------------------------------------------------------
The Mammography Quality Standards Act November 5, Do. Do.
Final Regulations Modifications and 2001
Additions to Policy Guidance Help
System 3; Guidance for
Industry and FDA (incorporated into
PGHS)
----------------------------------------------------------------------------------------------------------------
Compliance Guidance; The Mammography November 5, Do. Do.
Quality Standards Act Final 2001
Regulations--Preparing for MQSA
Inspections (incorporated into PGHS)
----------------------------------------------------------------------------------------------------------------
The Mammography Quality Standards Act March 25, 2002 Do. Do.
Final Regulations Modifications and
Additions to Policy Guidance Help
System 4; Guidance for
Industry and FDA (incorporated into
PGHS)
----------------------------------------------------------------------------------------------------------------
The Mammography Quality Standards Act July 8, 2002 Do. Do.
Final Regulations Modifications and
Additions to Policy Guidance Help
System 5; Guidance for
Industry and FDA (incorporated into
PGHS)
----------------------------------------------------------------------------------------------------------------
[[Page 863]]
The Mammography Quality Standards Act January 28, Do. Do.
Final Regulations Modifications and 2003
Additions to Policy Guidance Help
System 7; Guidance for
Industry and FDA (incorporated into
PGHS)
----------------------------------------------------------------------------------------------------------------
The Mammography Quality Standards Act August 19, 2003 Do. Do.
Final Regulations Modifications and
Additions to Policy Guidance Help
System 6 (incorporated into
PGHS)
----------------------------------------------------------------------------------------------------------------
Accidental Radioactive Contamination August 13, 1998 FDA, State and local agencies Do.
of Human Food and Animal Feeds:
Recommendations to State and Local
Agencies
----------------------------------------------------------------------------------------------------------------
Office of Device Evaluation
----------------------------------------------------------------------------------------------------------------
FY 2004 MDUFMA Small Business August 1, 2003 Office of Device Evaluation Do.
Qualification Worksheet and
Certification; Guidance for Industry
and FDA
----------------------------------------------------------------------------------------------------------------
Premarket Assessment of Pediatric July 24, 2003 Do. Do.
Medical Devices; Draft Guidance for
Industry and FDA Staff
----------------------------------------------------------------------------------------------------------------
Pediatric Expertise for Advisory June 3, 2003 Do. Do.
Panels; Guidance for Industry and FDA
Staff
----------------------------------------------------------------------------------------------------------------
Premarket Approval Application Filing May 1, 2003 Do. Do.
Review; Guidance for Industry and FDA
Staff
----------------------------------------------------------------------------------------------------------------
Guidance for Industry and FDA; FY 2003 March 27, 2003 Do. Do.
MDUFMA Small Business Qualification
Worksheet and Certification
----------------------------------------------------------------------------------------------------------------
Assessing User Fees: PMA Supplement February 21, Do. Do.
Definitions, Modular PMA Fees, BLA 2003
and Efficacy Supplement Definitions,
Bundling Multiple Devices in a Single
Application, and Fees for Combination
Products
----------------------------------------------------------------------------------------------------------------
Determination of Intended Use for December 3, Do. Do.
510(k) Devices; Guidance for CDRH 2002
Staff
----------------------------------------------------------------------------------------------------------------
The Least Burdensome Provisions of the October 4, 2002 Do. Do.
FDA Modernization Act of 1997:
Concept and Principles; Final
Guidance for FDA and Industry
----------------------------------------------------------------------------------------------------------------
Medical Devices Made With September 6, Do. Do.
Polyvinylchloride (PVC) Using the 2002
Plasticizer di-(2-
Ethylhexyl)phthalate (DEHP); Draft
Guidance for Industry and FDA
----------------------------------------------------------------------------------------------------------------
Updated 510(k) Sterility Review August 30, 2002 Do. Do.
Guidance K90-1; Final Guidance for
Industry and FDA
----------------------------------------------------------------------------------------------------------------
Availability of Information Given to July 18, 2001 Do. Do.
Advisory Committee Members in
Connection With CDRH Open Public
Panel Meetings; Draft Guidance for
Industry and FDA Staff
----------------------------------------------------------------------------------------------------------------
Humanitarian Device Exemptions (HDE) July 12, 2001 Do. Do.
Regulation: Questions and Answers;
Final Guidance for Industry
----------------------------------------------------------------------------------------------------------------
Changes or Modifications During the May 29, 2001 Do. Do.
Conduct of a Clinical Investigation;
Final Guidance for Industry and CDRH
Staff
----------------------------------------------------------------------------------------------------------------
Early Collaboration Meetings Under the February 28, Do. Do.
FDA Modernization Act (FDAMA); Final 2001
Guidance for Industry and for CDRH
Staff
----------------------------------------------------------------------------------------------------------------
[[Page 864]]
Deciding When To Submit a 510(k) for a November 30, Do. Do.
Change to an Existing Wireless 2000
Telemetry Medical Device; Final
Guidance for FDA Reviewers and
Industry
----------------------------------------------------------------------------------------------------------------
Guidance on Section 216 of the Food August 9, 2000 Do. Do.
and Drug Administration Modernization
Act of 1997
----------------------------------------------------------------------------------------------------------------
Guidance on Amended Procedures for July 22, 2000 Do. Do.
Advisory Panel Meetings; Final
----------------------------------------------------------------------------------------------------------------
Guidance on the Use of Standards in March 12, 2000 Do. Do.
Substantial Equivalence
Determinations; Final
----------------------------------------------------------------------------------------------------------------
Guidance for Off-the-Shelf Software September 9, Do. Do.
Use in Medical Devices; Final 1999
----------------------------------------------------------------------------------------------------------------
Draft Guidance on Evidence Models for September 1, Do. Do.
the Least Burdensome Means to Market 1999
----------------------------------------------------------------------------------------------------------------
Medical Devices Containing Materials November 16, Do. Do.
Derived from Animal Sources (Except 1998
In Vitro Diagnostic Devices); Final
Guidance for FDA Reviewers and
Industry
----------------------------------------------------------------------------------------------------------------
Guidance for the Medical Device November 6, Do. Do.
Industry on PMA Shell Development and 1998
Modular Review; Final
----------------------------------------------------------------------------------------------------------------
Guidance for Industry; General/ November 4, Do. Do.
Specific Intended Use; Final 1998
----------------------------------------------------------------------------------------------------------------
Frequently Asked Questions on the New October 22, Do. Do.
510(k) Paradigm; Final 1998
----------------------------------------------------------------------------------------------------------------
Modifications to Devices Subject to August 6, 1998 Do. Do.
Premarket Approval--The PMA
Supplement Decision Making Process;
Draft
----------------------------------------------------------------------------------------------------------------
Guidance for Industry; Contents of a July 27, 1998 Do. Do.
Product Development Protocol; Draft
----------------------------------------------------------------------------------------------------------------
New Model Medical Device Development July 21, 1998 Do. Do.
Process; Final
----------------------------------------------------------------------------------------------------------------
Guidance for the Content of Premarket May 29, 1998 Do. Do.
Submissions for Software Contained in
Medical Devices; Final
----------------------------------------------------------------------------------------------------------------
Guidance to Industry Supplements to May 20, 1998 Do. Do.
Approved Applications for Class III
Medical Devices: Use of Published
Literature, Use of Previously
Submitted Materials, and Priority
Review; Final
----------------------------------------------------------------------------------------------------------------
A New 510(k) Paradigm--Alternate March 20, 1998 Do. Do.
Approaches to Demonstrating
Substantial Equivalence in Premarket
Notifications
----------------------------------------------------------------------------------------------------------------
PMA/510(k) Expedited Review; Guidance March 20, 1998 Do. Do.
for Industry and CDRH Staff; Final
----------------------------------------------------------------------------------------------------------------
PMA/510(k) Expedited Review G94-4 March 20, 1998 Do. Do.
(blue book memo)
----------------------------------------------------------------------------------------------------------------
30-Day Notices and 135-Day PMA February 19, Do. Do.
Supplements for Manufacturing Method 1998
or Process Changes; Guidance for
Industry and CDRH (Docket No. 98D-
0080); Final
----------------------------------------------------------------------------------------------------------------
Guidance on PMA Interactive Procedures February 19, Do. Do.
for Day-100 Meetings and Subsequent 1998
Deficiencies--for Use by CDRH and
Industry; Final
----------------------------------------------------------------------------------------------------------------
[[Page 865]]
New section 513(f)(2)--Evaluation of February 19, Do. Do.
Automatic Class III Designation; 1998
Guidance for Industry and CDRH Staff;
Final
----------------------------------------------------------------------------------------------------------------
Procedures for Class II Device February 19, Do. Do.
Exemptions from Premarket 1998
Notification Guidance for Industry
and CDRH Staff; Final
----------------------------------------------------------------------------------------------------------------
Guidance on IDE Policies and January 20, Do. Do.
Procedures; Final 1998
----------------------------------------------------------------------------------------------------------------
Distribution and Public Availability October 10, Do. Do.
of PMA Summary of Safety and 1997
Effectiveness Data Packages
----------------------------------------------------------------------------------------------------------------
Kit Certification for 510(k)s July 1, 1997 Do. Do.
----------------------------------------------------------------------------------------------------------------
Convenience Kits Interim Regulatory May 20, 1997 Do. Do.
Guidance
----------------------------------------------------------------------------------------------------------------
Real-Time Review Program for Premarket April 22, 1997 Do. Do.
Aproval Application (PMA) Supplements
----------------------------------------------------------------------------------------------------------------
Deciding When to Submit a 510(k) for a January 10, Do. Do.
Change to an Existing Device (K97-1) 1997
----------------------------------------------------------------------------------------------------------------
Questions and Answers for the FDA September 3, Do. Do.
Reviewer Guidance: Labeling Reusable 1996
Medical Devices for Reprocessing in
Health Care Facilities
----------------------------------------------------------------------------------------------------------------
Memorandum of Understanding Regarding August 9, 1996 Do. Do.
Patient Labeling Review (blue book
memo G96-3)
----------------------------------------------------------------------------------------------------------------
Continued Access to Investigational July 15, 1996 Do. Do.
Devices During PMA Preparation and
Review (blue book memo D96-
1)
----------------------------------------------------------------------------------------------------------------
Document Review by the Office of the June 6, 1996 Do. Do.
Chief Counsel (blue book memo G96-1)
----------------------------------------------------------------------------------------------------------------
Format for IDE Progress Reports June 1, 1996 Do. Do.
----------------------------------------------------------------------------------------------------------------
Labeling Reusable Medical Devices for April 1, 1996 Do. Do.
Reprocessing in Health Care
Facilities: FDA Reviewer Guidance
----------------------------------------------------------------------------------------------------------------
510(k) Quality Review Program (blue March 29, 1996 Do. Do.
book memo)
----------------------------------------------------------------------------------------------------------------
Suggested Content for Original IDE February 27, Do. Do.
Application Cover Letter 1996
----------------------------------------------------------------------------------------------------------------
Indications for Use Statement January 2, 1996 Do. Do.
----------------------------------------------------------------------------------------------------------------
Letter--Vascular Graft Industry November 22, Do. Do.
(Philip Phillips) 1995
----------------------------------------------------------------------------------------------------------------
Cover Letter: 510(k) Requirements November 21, Do. Do.
During Firm-Initiated Recalls; 1995
Attachment A: Guidance on Recall and
Premarket Notification Review
Procedures During Firm-Initiated
Recalls of Legally Marketed Devices
(blue book memo K95-1)
----------------------------------------------------------------------------------------------------------------
Color Additives for Medical Devices November 15, Do. Do.
(Snesko) 1995
----------------------------------------------------------------------------------------------------------------
D95-2, Attachment A September 15, Do. Do.
(Interagency Agreement between FDA 1995
and HCFA)
----------------------------------------------------------------------------------------------------------------
D95-2, Attachment B (Criteria September 15, Do. Do.
for Categorization of Investigational 1995
Devices (HCFA))
----------------------------------------------------------------------------------------------------------------
[[Page 866]]
HCFA Reimbursement Categorization September 15, Do. Do.
Determinations for FDA-Approved IDEs 1995
----------------------------------------------------------------------------------------------------------------
Implementation of the FDA/HCFA September 15, Do. Do.
Interagency Agreement Regarding 1995
Reimbursement Categorization of
Investigational Devices, Attachment A
Interagency Agreement, Attachment B
Criteria for Catergorization of
Investigational Devices, and
Attachment C--List (blue book memo
D95-2)
----------------------------------------------------------------------------------------------------------------
Goals and Initiatives for the IDE July 12, 1995 Do. Do.
Program (blue book memo D95-
1)
----------------------------------------------------------------------------------------------------------------
Memorandum: Electromagnetic June 13, 1995 Do. Do.
Compatibility for Medical Devices:
Issues and Solutions
----------------------------------------------------------------------------------------------------------------
Use of International Standard ISO- May 1, 1995 Do. Do.
10993, ``Biological Evaluation of
Medical Devices Part 1: Evaluation
and Testing'' (replaces G87-
1 8294) (blue book memo)
----------------------------------------------------------------------------------------------------------------
Premarket Approval Application (PMA) July 8, 1994 Do. Do.
Closure (blue book memo P94-
2)
----------------------------------------------------------------------------------------------------------------
510(k) Sign-Off Procedures (blue book June 3, 1994 Do. Do.
memo K94-2)
----------------------------------------------------------------------------------------------------------------
Letter to Industry, Powered Wheelchair/ May 26, 1994 Do. Do.
Scooter or Accessory/Component
Manufacturer from Susan Alpert,
Ph.D., M.D.
----------------------------------------------------------------------------------------------------------------
510(k) Refuse to Accept Procedures May 20, 1994 Do. Do.
(blue book memo K94-1)
----------------------------------------------------------------------------------------------------------------
IDE Refuse to Accept Procedures (blue May 20, 1994 Do. Do.
book memo D94-1)
----------------------------------------------------------------------------------------------------------------
PMA/510(k) Triage Review Procedures May 20, 1994 Do. Do.
(blue book memo G94-1)
----------------------------------------------------------------------------------------------------------------
Preamendments Class III Strategy April 19, 1994 Do. Do.
----------------------------------------------------------------------------------------------------------------
Premarket Notification (510(k)) Status March 7, 1994 Do. Do.
Request Form
----------------------------------------------------------------------------------------------------------------
Documentation and Resolution of December 23, Do. Do.
Differences of Opinion on Product 1993
Evaluations (blue book memo < greek-
i>G93-1)
----------------------------------------------------------------------------------------------------------------
510(k) Additional Information July 23, 1993 Do. Do.
Procedures (blue book memo < greek-
i>K93-1)
----------------------------------------------------------------------------------------------------------------
CDRH's Investigational Device June 30, 1993 Do. Do.
Exemption (IDE) Refuse to Accept
Policy
----------------------------------------------------------------------------------------------------------------
CDRH's Premarket Notification (510(k)) June 30, 1993 Do. Do.
Refuse to Accept Policy (updated
checklist March 14, 1995)
----------------------------------------------------------------------------------------------------------------
Proposal for Establishing Mechanisms June 30, 1993 Do. Do.
for Setting Review Priorities Using
Risk Assesment and Allocating Review
Resources
----------------------------------------------------------------------------------------------------------------
Classified Convenience Kits April 30, 1993 Do. Do.
----------------------------------------------------------------------------------------------------------------
Telephone Communications Between ODE January 29, Do. Do.
Staff and Manufacturers (blue book 1993
memo I93-1)
----------------------------------------------------------------------------------------------------------------
Preamendment Class III Devices March 11, 1992 Do. Do.
----------------------------------------------------------------------------------------------------------------
Nondisclosure of Financially Sensitive March 5, 1992 Do. Do.
Information (blue book memo < greek-
i>I92-1)
----------------------------------------------------------------------------------------------------------------
[[Page 867]]
Document Review Processing (blue book February 12, Do. Do.
memo I91-1) 1992
----------------------------------------------------------------------------------------------------------------
4-of-a-Kind PMAs October 1, 1991 Do. Do.
----------------------------------------------------------------------------------------------------------------
Review of 510(k)s for Computer August 29, 1991 Do. Do.
Controlled Medical Devices (blue book
memo K91-1)
----------------------------------------------------------------------------------------------------------------
Review of Final Draft Medical Device August 29, 1991 Do. Do.
Labeling (blue book memo P91-
4)
----------------------------------------------------------------------------------------------------------------
Integrity of Data and Information May 29, 1991 Do. Do.
Submitted to ODE (blue book memo
I91-2)
----------------------------------------------------------------------------------------------------------------
Clinical Utility and Premarket May 3, 1991 Do. Do.
Approval (blue book memo P91-
1)
----------------------------------------------------------------------------------------------------------------
Panel Review of Premarket Approval May 3, 1991 Do. Do.
Applications (blue book memo < greek-
i>P91-2)
----------------------------------------------------------------------------------------------------------------
PMA Compliance Program (blue book memo May 3, 1991 Do. Do.
P91-3)
----------------------------------------------------------------------------------------------------------------
Shelf Life of Medical Devices April 1, 1991 Do. Do.
----------------------------------------------------------------------------------------------------------------
Device Labeling Guidance (blue book March 8, 1991 Do. Do.
memo G91-1)
----------------------------------------------------------------------------------------------------------------
Review and Approval of PMAs of October 22, Do. Do.
Licensees (blue book memo < greek- 1990
i>P86-4)
----------------------------------------------------------------------------------------------------------------
Consolidated Review of Submissions for October 19, Do. Do.
Diagnostic Ultrasound Equipment, 1990
Accessories and Related Measurement
Devices (blue book memo G90-
2)
----------------------------------------------------------------------------------------------------------------
Consolidated Review of Submissions for October 19, Do. Do.
Lasers and Accessories (blue book 1990
memo G90-1)
----------------------------------------------------------------------------------------------------------------
Assignment of Review Documents (blue August 24, 1990 Do. Do.
book memo I90-2)
----------------------------------------------------------------------------------------------------------------
PMA Supplements: ODEs Letter to April 24, 1990 Do. Do.
Manufacturers; Identifies Situations
Which May Require the Submission of a
PMA Supplement (When PMA Supplements
Are Required) (blue book memo < greek-
i>P90-1)
----------------------------------------------------------------------------------------------------------------
Policy Development and Review February 15, Do. Do.
Procedures (blue book memo < greek- 1990
i>I90-1)
----------------------------------------------------------------------------------------------------------------
Substantial Equivalence (SE) Decision January 1, 1990 Do. Do.
Making Documentation Attached: ``SE''
Decision Making Process (detailed);
i.e., The Decision Making Tree
----------------------------------------------------------------------------------------------------------------
Threshold Assessment of the Impact of January 1, 1990 Do. Do.
Requirements for Submission of PMAs
for 31 Medical Devices Marketed Prior
to May 28, 1976
----------------------------------------------------------------------------------------------------------------
Meetings with the Regulated Industry November 20, Do. Do.
(blue book memo I89-3) 1989
----------------------------------------------------------------------------------------------------------------
FDA Policy for The Regulation of November 13, Do. Do.
Computer Products; Draft 1989
----------------------------------------------------------------------------------------------------------------
Toxicology Risk Assessment Committee August 9, 1989 Do. Do.
(blue book memo G89-1)
----------------------------------------------------------------------------------------------------------------
Review of IDEs for Feasibility Studies May 17, 1989 Do. Do.
(blue book memo D89-1)
----------------------------------------------------------------------------------------------------------------
[[Page 868]]
Premarket Notification--Consistency of February 28, Do. Do.
Reviews (blue book memo K89- 1989
1)
----------------------------------------------------------------------------------------------------------------
Review of Laser Submissions (blue book April 15, 1988 Do. Do.
memo G88-1)
----------------------------------------------------------------------------------------------------------------
PMA Review Schedules (P87-1); replaced March 31, 1988 Do. Do.
by P94-2
----------------------------------------------------------------------------------------------------------------
Guideline on Validation of the Limulus December 1, Do. Do.
Amebocyte Lysate (LAL) Test as an End- 1987
Product Endotoxin Test
----------------------------------------------------------------------------------------------------------------
Necessary Information for Diagnostic November 24, Do. Do.
Ultrasound 510(k); Draft 1987
----------------------------------------------------------------------------------------------------------------
Limulus Amebocute Lysate; Reduction of October 23, Do. Do.
Samples for Testing 1987
----------------------------------------------------------------------------------------------------------------
ODE Executive Secretary Guidance August 7, 1987 Do. Do.
Manual G87-3
----------------------------------------------------------------------------------------------------------------
Guideline on Sterile Drug Products June 1, 1987 Do. Do.
Produced by Aseptic Processing
----------------------------------------------------------------------------------------------------------------
Master Files Part III; Guidance on June 1, 1987 Do. Do.
Scientific and Technical Information
----------------------------------------------------------------------------------------------------------------
ODE Regulatory Information for the May 15, 1987 Do. Do.
Office of Compliance--Information
Sharing Procedures (blue book memo
G87-2)
----------------------------------------------------------------------------------------------------------------
Guideline on General Principles of May 1, 1987 Do. Do.
Process Validation
----------------------------------------------------------------------------------------------------------------
Industry Representatives on Scientific March 27, 1987 Do. Do.
Panel
----------------------------------------------------------------------------------------------------------------
Panel Review of ``Me-Too'' Devices July 1, 1986 Do. Do.
(blue book memo P86-6)
----------------------------------------------------------------------------------------------------------------
Guidance on CDRH's Premarket June 30, 1986 Do. Do.
Notification Review Program (blue
book memo K86-3)
----------------------------------------------------------------------------------------------------------------
Panel Report and Recommendations on April 18, 1986 Do. Do.
PMA Approvals (blue book memo < greek-
i>P86-5)
----------------------------------------------------------------------------------------------------------------
Criteria for Panel Review of PMA January 30, Do. Do.
Supplements (blue book memo < greek- 1986
i>P86-3)
----------------------------------------------------------------------------------------------------------------
PMAs--Early Review and Preparation of January 27, Do. Do.
Summaries of Safety and Effectiveness 1986
(blue book memo P86-1)
----------------------------------------------------------------------------------------------------------------
PTC in the Characterization of Cell June 1, 1984 Do. Do.
Lines Used to Produce Biological
Products
----------------------------------------------------------------------------------------------------------------
Application of the Device Good December 1, Do. Do.
Manufacturing Practice (GMP) 1983
Regulation to the Manufacture of
Sterile Devices
----------------------------------------------------------------------------------------------------------------
Methods for Conducting Recall June 16, 1978 Do. Do.
Effectiveness Checks
----------------------------------------------------------------------------------------------------------------
Guidance for Submitting 1997 Do. Do.
Reclassification Petition
----------------------------------------------------------------------------------------------------------------
Reprocessing and Reuse of Single-Use February 8, Do. Do.
Devices: Review Prioritization 2000
Scheme; Draft
----------------------------------------------------------------------------------------------------------------
Class II Special Controls Guidance July 17, 2002 Do. Do.
Document: Apnea Monitors; Guidance
for Industry and FDA
----------------------------------------------------------------------------------------------------------------
Class II Special Controls Guidance December 13, Do. Do.
Document: Cutaneous Carbon Dioxide 2002
(PcCo2) and Oxygen (PcO2) Monitors;
Guidance for Industry and FDA
----------------------------------------------------------------------------------------------------------------
[[Page 869]]
Class II Special Controls Guidance October 5, 2001 Do. Do.
Document: Indwelling Blood Gas
Analyzers; Final Guidance for
Industry and FDA
----------------------------------------------------------------------------------------------------------------
Heated Humidifier Review Guidance August 30, 1991 Do. Do.
----------------------------------------------------------------------------------------------------------------
Class II Special Controls Guidance April 22, 2003 Do. Do.
Document: Optical Impression Systems
for Computer Assisted Design and
Manufacturing (CAD/CAM) of Dental
Restorations; Guidance for Industry
and FDA
----------------------------------------------------------------------------------------------------------------
Class II Special Controls Guidance November 12, Do. Do.
Document: Intraoral Devices for 2002
Snoring and/or Obstructive Sleep
Apnea; Guidance for Industry and FDA
----------------------------------------------------------------------------------------------------------------
Class II Special Controls Guidance August 14, 2002 Do. Do.
Document: Dental Sonography and Jaw
Tracking Devices; Draft Guidance for
Industry and FDA Reviewers
----------------------------------------------------------------------------------------------------------------
Class II Special Controls Guidance May 14, 2002 Do. Do.
Document: Root-Form Endosseous Dental
Implants and Abutments; Draft
Guidance for Industry and FDA
----------------------------------------------------------------------------------------------------------------
Special Control Guidance Document on February 20, Do. Do.
Encapsulated Amalgam, Amalgam Alloy, 2002
and Dental Mercury Labeling; Draft
Guidance for Industry and FDA
----------------------------------------------------------------------------------------------------------------
Overview of Information Necessary for April 21, 1999 Do. Do.
Premarket Notification Submissions
for Endosseous Implants; Final
----------------------------------------------------------------------------------------------------------------
Guidance for the Preparation of November 27, Do. Do.
Premarket Notifications for Dental 1998
Composites
----------------------------------------------------------------------------------------------------------------
Dental Cements--Premarket August 18, 1998 Do. Do.
Notification; Final
----------------------------------------------------------------------------------------------------------------
Dental Impression Materials--Premarket August 17, 1998 Do. Do.
Notification; Final
----------------------------------------------------------------------------------------------------------------
OTC Denture Cushions, Pads, Reliners, August 17, 1998 Do. Do.
Repair Kits, and Partially Fabricated
Denture Kits; Final
----------------------------------------------------------------------------------------------------------------
Draft Guidance Document for the March 3, 1997 Do. Do.
Preparation of Premarket Notification
510(k)s for Dental Alloys
----------------------------------------------------------------------------------------------------------------
Information Necessary for Premarket December 9, Do. Do.
Notification Submissions for Screw- 1996
Type Endosseous Implants
----------------------------------------------------------------------------------------------------------------
Guidance Document on Dental Handpieces July 1, 1995 Do. Do.
----------------------------------------------------------------------------------------------------------------
Guidance for the Arrangement and May 16, 1989 Do. Do.
Content of a Premarket Approval (PMA)
Application for an Endosseous Implant
for Prosthetic Attachment
----------------------------------------------------------------------------------------------------------------
Supplementary Guidance on Premarket December 31, Do. Do.
Notifications for Medical Devices 2002
With Sharps Injury Prevention
Features; Guidance for Industry and
FDA
----------------------------------------------------------------------------------------------------------------
Guidance on Premarket Notifications October 12, Do. Do.
for Intravascular Administration Sets 2000
----------------------------------------------------------------------------------------------------------------
Neonatal and Neonatal Transport September 18, Do. Do.
Incubators--Premarket Notifications; 1998
Final
----------------------------------------------------------------------------------------------------------------
Guidance on the Content of Premarket December 1, Do. Do.
Notification (510(k)) Submissions for 1995
Protective Restraints
----------------------------------------------------------------------------------------------------------------
[[Page 870]]
Guidance on Premarket Notification March 16, 1995 Do. Do.
(510(k)) Submissions for Short-Term
and Long-Term Intravascular Catheters
----------------------------------------------------------------------------------------------------------------
Guidance on the Content of Premarket April 1, 1993 Do. Do.
Notification (510(k)) Submissions for
Hypodermic Single Lumen Needles
----------------------------------------------------------------------------------------------------------------
Guidance on the Content of Premarket April 1, 1993 Do. Do.
Notification (510(k)) Submissions for
Piston Syringes
----------------------------------------------------------------------------------------------------------------
Guidance on the Content of Premarket March 1, 1993 Do. Do.
Notification (510(k)) Submissions for
Clinical Electronic Thermometers
----------------------------------------------------------------------------------------------------------------
Guidance on the Content of Premarket March 1, 1993 Do. Do.
Notification (510(k)) Submissions for
External Infusion Pumps
----------------------------------------------------------------------------------------------------------------
Guidance on 510(k) Submissions for October 1, 1990 Do. Do.
Implanted Infusion Ports
----------------------------------------------------------------------------------------------------------------
Surgical Masks--Premarket Notification May 15, 2003 Do. Do.
(510(k)) Submissions; Draft Guidance
----------------------------------------------------------------------------------------------------------------
Regulatory Status of Disinfectants August 30, 2002 Do. Do.
Used to Process Dialysate Delivery
Systems and Water Purification
Systems for Hemodialysis; Guidance
for Industry and FDA
----------------------------------------------------------------------------------------------------------------
Premarket Notification (510(k)) March 7, 2002 Do. Do.
Submissions for Medical Sterilization
Packaging Systems in Health Care
Facilities; Draft Guidance for
Industry and FDA
----------------------------------------------------------------------------------------------------------------
Class II Special Controls Guidance February 7, Do. Do.
Document: Medical Washers and Medical 2002
Washer-Disinfectors; Guidance for the
Medical Device Industry and FDA
Review Staff
----------------------------------------------------------------------------------------------------------------
Premarket Guidance: Reprocessing and June 1, 2001 Do. Do.
Reuse of Single-Use Devices; Draft
Guidance for Industry and FDA Staff
----------------------------------------------------------------------------------------------------------------
Premarket Notifications (510(k)) for May 21, 2001 Do. Do.
Biological Indicators Intended to
Monitor Sterilizers Used in Health
Care Facilities; Draft Guidance for
Industry and FDA Reviewers
----------------------------------------------------------------------------------------------------------------
Premarket Approval Applications (PMA) March 2, 2001 Do. Do.
for Sharps Needle Destruction
Devices; Final Guidance for Industry
and FDA
----------------------------------------------------------------------------------------------------------------
Guidance on the Content and Format of January 3, 2000 Do. Do.
Premarket Notification (510(k))
Submissions for Liquid Chemical
Sterilants and High Level
Disinfectants; Final
----------------------------------------------------------------------------------------------------------------
Guidance for Conducting Stability November 16, Do. Do.
Testing to Support an Expiration Date 1999
Labeling Claim for Medical Gloves;
Draft
----------------------------------------------------------------------------------------------------------------
Premarket Notification (510(k)) January 13, Do. Do.
Submissions for Testing for Skin 1999
Sensitization to Chemicals in Natural
Rubber Products; Final
----------------------------------------------------------------------------------------------------------------
CDRH Regulatory Guidance for Washers June 2, 1998 Do. Do.
and Washer-Disinfectors Intended for
Use in Processing Reusable Medical
Devices
----------------------------------------------------------------------------------------------------------------
Testing for Sensitizing Chemicals in July 28, 1997 Do. Do.
Natural Rubber Latex Medical Devices
(addendum to 944)
----------------------------------------------------------------------------------------------------------------
[[Page 871]]
Addendum to Guidance on Premarket September 19, Do. Do.
Notification (510(k)) Submissions for 1995
Sterilizers Intended for Use in
Health Care Facilities
----------------------------------------------------------------------------------------------------------------
Guidance on the Content and Format of October 1, 1993 Do. Do.
Premarket Notification (510(k))
Submissions for Sharps Containers
----------------------------------------------------------------------------------------------------------------
Guidance on Premarket Notification August 1, 1993 Do. Do.
(510(k)) Submissions for Automated
Endoscope Washers, Washer/
Disinfectors, and Disinfectors
Intended for Use in Health Care
Facilities
----------------------------------------------------------------------------------------------------------------
Guidance on Premarket Notification August 1, 1993 Do. Do.
(510(k)) Submissions for Surgical
Gowns and Surgical Drapes
----------------------------------------------------------------------------------------------------------------
Guidance on Premarket Notification March 1, 1993 Do. Do.
510(k) for Sterilizers Intended for
Use in Health Care Facilities
----------------------------------------------------------------------------------------------------------------
Battery Guidance January 1, 1994 Do. Do.
----------------------------------------------------------------------------------------------------------------
Policy for Expiration Dating (DCRND October 30, Do. Do.
RB92-G) 1992
----------------------------------------------------------------------------------------------------------------
Balloon Valvuloplasty Guidance for the January 1, 1989 Do. Do.
Submission of an IDE Application and
a PMA Application
----------------------------------------------------------------------------------------------------------------
Cardiac Ablation Catheters Generic July 1, 2002 Do. Do.
Arrhythmia Indications for Use;
Guidance for Industry
----------------------------------------------------------------------------------------------------------------
Investigational Device Exemption (IDE) November 8, Do. Do.
Study Enrollment for Cardiac Ablation 2000
of Typical Atrial Flutter; Final
Guidance for Industry and FDA
Reviewers
----------------------------------------------------------------------------------------------------------------
Recommended Clinical Study Design for May 7, 1999 Do. Do.
Ventricular Tachycardia Ablation
----------------------------------------------------------------------------------------------------------------
Non-Automated Sphygmomanometer (Blood November 19, Do. Do.
Pressure Cuff) Guidance Version 1; 1998
Final
----------------------------------------------------------------------------------------------------------------
Non-Invasive Blood Pressure (NIBP) March 10, 1997 Do. Do.
Monitor Guidance
----------------------------------------------------------------------------------------------------------------
Electrocardiograph (ECG) Electrode February 11, Do. Do.
1997
----------------------------------------------------------------------------------------------------------------
Electrocardiograph (ECG) Lead February 11, Do. Do.
Switching Adapter 1997
----------------------------------------------------------------------------------------------------------------
Electrocardiograph (ECG) Surface February 11, Do. Do.
Electrode Tester 1997
----------------------------------------------------------------------------------------------------------------
Draft Version Cardiac Ablation March 1, 1995 Do. Do.
Preliminary Guidance (Data To Be
Submitted to the FDA in Support
Investigation Device Exemption
Application)
----------------------------------------------------------------------------------------------------------------
Draft Version Electrode Recording March 1, 1995 Do. Do.
Catheter Preliminary Guidance (Data
To Be Submitted to the FDA in Support
of Premarket Notifications)
----------------------------------------------------------------------------------------------------------------
Guidance for Annuloplasty Rings 510(k) January 31, Do. Do.
Submissions; Final Guidance for 2001
Industry and FDA Staff
----------------------------------------------------------------------------------------------------------------
Guidance for Cardiopulmonary Bypass November 29, Do. Do.
Arterial Line Blood Filter 510(k) 2000
Submissions; Final Guidance for
Industry and FDA
----------------------------------------------------------------------------------------------------------------
Guidance for Extracorporeal Blood November 29, Do. Do.
Circuit Defoamer 510(k) Submissions; 2000
Final Guidance for Industry and FDA
----------------------------------------------------------------------------------------------------------------
[[Page 872]]
Guidance for Cardiopulmonary Bypass November 13, Do. Do.
Oxygenators 510(k) Submissions; Final 2000
Guidance for Industry and FDA Staff
----------------------------------------------------------------------------------------------------------------
Draft Replacement Heart Valve Guidance October 14, Do. Do.
1994
----------------------------------------------------------------------------------------------------------------
Draft Guidance; Human Heart Valve June 21, 1991 Do. Do.
Allografts
----------------------------------------------------------------------------------------------------------------
Guidance for the Preparation of the April 1, 1990 Do. Do.
Annual Report to the PMA Approved
Heart Valve Prostheses
----------------------------------------------------------------------------------------------------------------
Draft Intravascular Brachytherapy-- May 24, 1996 Do. Do.
Guidance for Data To Be Submitted to
FDA in Support of Investigational
Device Exemption (IDE) Applications
----------------------------------------------------------------------------------------------------------------
Draft Guidance for the Submission of May 1, 1995 Do. Do.
Research and Marketing Applications
for Interventional Cardiology
Devices: PTCA Catheters, Atherectomy
Catheters, Lasers, Intravascular
Stents
----------------------------------------------------------------------------------------------------------------
Draft Percutaneous Transluminal February 7, Do. Do.
Coronary Angioplasty Package Insert 1995
Template
----------------------------------------------------------------------------------------------------------------
Coronary and Cerebrovascular Guidewire January 1, 1995 Do. Do.
Guidance
----------------------------------------------------------------------------------------------------------------
Guidance for the Submission of November 1, Do. Do.
Research and Marketing Applications 2000
for Permanent Pacemaker Leads and for
Pacemaker Lead Adaptor 510(k)
Submissions
----------------------------------------------------------------------------------------------------------------
Draft Guidance for Implantable June 19, 1996 Do. Do.
Cardioverter-Defibrillators
----------------------------------------------------------------------------------------------------------------
Implantable Pacemaker Testing Guidance January 12, Do. Do.
1990
----------------------------------------------------------------------------------------------------------------
Guidance Document for Vascular November 1, Do. Do.
Prostheses 510(k) Submissions 2000
----------------------------------------------------------------------------------------------------------------
Guidance for Cardiovascular November 26, Do. Do.
Intravascular Filter 510(k) 1999
Submissions; Final
----------------------------------------------------------------------------------------------------------------
Carotid Stent--Suggestions for Content October 26, Do. Do.
of Submissions to FDA in Support of 1996
Investigational Devices Exemption
(IDE) Applications
----------------------------------------------------------------------------------------------------------------
Draft Guidance for the Preparation of August 1, 1993 Do. Do.
Research and Marketing Applications
for Vascular Graft Prostheses
----------------------------------------------------------------------------------------------------------------
Guidance Document for Powered Suction September 30, Do. Do.
Pump 510(k)s 1998
----------------------------------------------------------------------------------------------------------------
Guidance Document for Surgical Lamp July 13, 1998 Do. Do.
510(k)s; Final
----------------------------------------------------------------------------------------------------------------
Electroencephalograph Devices Draft November 3, Do. Do.
Guidance for 510(k) Content 1997
----------------------------------------------------------------------------------------------------------------
Guidelines for Reviewing Premarket February 1, Do. Do.
Notifications That Claim Substantial 1997
Equivalence to Evoked Response
Stimulators
----------------------------------------------------------------------------------------------------------------
Guidance Document for the Preparation July 26, 1995 Do. Do.
of Premarket Notification (510(k))
Applications for Electromyograph
Needle Electrodes
----------------------------------------------------------------------------------------------------------------
Guidance on the Content and June 1, 1995 Do. Do.
Organization of a Premarket
Notification for a Medical Laser
----------------------------------------------------------------------------------------------------------------
[[Page 873]]
Draft 510(k) Guideline for General May 10, 1995 Do. Do.
Surgical Electrosurgical Devices
----------------------------------------------------------------------------------------------------------------
Guidance for the Preparation of a August 30, 1994 Do. Do.
Premarket Notification for Extended
Laparoscopy Devices
----------------------------------------------------------------------------------------------------------------
Galvanic Skin Response Measurement August 23, 1994 Do. Do.
Devices; Draft Guidance for 510(k)
Content
----------------------------------------------------------------------------------------------------------------
Draft Version 1; Biofeedback Devices; August 1, 1994 Do. Do.
Draft Guidance for 510(k) Content
----------------------------------------------------------------------------------------------------------------
Draft Version Cranial Perforator July 13, 1994 Do. Do.
Guidance
----------------------------------------------------------------------------------------------------------------
Draft Version Neuro Endoscope Guidance July 7, 1994 Do. Do.
----------------------------------------------------------------------------------------------------------------
Draft Premarket Notification Review June 1, 1994 Do. Do.
Guidance for Evoked Response
Somatosensory Stimulators
----------------------------------------------------------------------------------------------------------------
Draft Guidance for Arthroscope and May 1, 1994 Do. Do.
Accessory 510(k)s
----------------------------------------------------------------------------------------------------------------
Class II Special Controls Guidance January 16, Do. Do.
Document; Knee Joint 2003
Patellofemorotibial and Femorotibial
Metal/Polymer Porous-Coated
Uncemented Prostheses; Guidance for
Industry and FDA
----------------------------------------------------------------------------------------------------------------
Class II Special Controls Guidance July 17, 2002 Do. Do.
Document; Polymethylmethacrylate
(PMMA) Bone Cement; Guidance for
Industry and FDA
----------------------------------------------------------------------------------------------------------------
Class II Special Controls Guidance April 30, 2002 Do. Do.
Document: Hip Joint Metal/Polymer
Constrained Cemented or Uncemented
Prosthesis
----------------------------------------------------------------------------------------------------------------
Class II Special Controls Guidance: October 31, Do. Do.
Shoulder Joint Metal/Polymer/Metal 2000
Nonconstrained or Semiconstrained
Porous-Coated Uncemented Prosthesis
----------------------------------------------------------------------------------------------------------------
Guidance for Spinal System 510(k)s September 27, Do. Do.
2000
----------------------------------------------------------------------------------------------------------------
Guidance Document for the Preparation January 13, Do. Do.
of IDEs for Spinal Systems 2000
----------------------------------------------------------------------------------------------------------------
Guidance Document for Industry and March 18, 1998 Do. Do.
CDRH Staff for the Preparation of
Investigational Device Exemptions and
Premarket Approval Applications for
Bone Growth Stimulator Devices; Draft
----------------------------------------------------------------------------------------------------------------
Draft Guidance Document for the July 16, 1997 Do. Do.
Preparation of Premarket Notification
(510(k)) Applications for Orthopedic
Devices--The Basic Elements
----------------------------------------------------------------------------------------------------------------
ORDB 510(k) Sterility Review Guidance July 3, 1997 Do. Do.
----------------------------------------------------------------------------------------------------------------
Calcium Phosphate (Ca-P) Coating Draft February 21, Do. Do.
Guidance for Preparation of FDA 1997
Submissions for Orthopedic and Dental
Endosseous Implants
----------------------------------------------------------------------------------------------------------------
Reviewers Guidance Checklist for February 21, Do. Do.
Intramedullary Rods 1997
----------------------------------------------------------------------------------------------------------------
Reviewers Guidance Checklist for February 21, Do. Do.
Orthopedic External Fixation Devices 1997
----------------------------------------------------------------------------------------------------------------
510(k) Information Needed for February 20, Do. Do.
Hydroxyapatite Coated Orthopedic 1997
Implants
----------------------------------------------------------------------------------------------------------------
[[Page 874]]
Guidance Document for Testing April 20, 1996 Do. Do.
Biodegradable Polymer Implant Devices
----------------------------------------------------------------------------------------------------------------
Guidance Document for Testing Bone April 20, 1996 Do. Do.
Anchor Devices
----------------------------------------------------------------------------------------------------------------
Draft Guidance Document for Femoral August 1, 1995 Do. Do.
Stem Prostheses
----------------------------------------------------------------------------------------------------------------
Draft Guidance Document for Testing May 1, 1995 Do. Do.
Acetabular Cup Prostheses
----------------------------------------------------------------------------------------------------------------
Guidance Document for Testing Non- May 1, 1995 Do. Do.
Articulating, ``Mechanically
Locked,'' Modular Implant Components
----------------------------------------------------------------------------------------------------------------
Draft Data Requirements for Ultrahigh March 28, 1995 Do. Do.
Molecular Weight Polyethylene
(Uhmupe) Used in Orthopedic Devices
----------------------------------------------------------------------------------------------------------------
Guidance Document for the Preparation January 10, Do. Do.
of Premarket Notification for Ceramic 1995
Ball Hip Systems
----------------------------------------------------------------------------------------------------------------
Guidance Document for Testing April 28, 1994 Do. Do.
Orthopedic Implants With Modified
Metallic Surfaces Apposing Bone or
Bone Cement
----------------------------------------------------------------------------------------------------------------
Draft Guidance for the Preparation of April 1, 1993 Do. Do.
Premarket Notifications (510(k)s) for
Cemented, Semiconstrained Total Knee
Prostheses
----------------------------------------------------------------------------------------------------------------
Guidance Document for the Preparation February 18, Do. Do.
of IDE and PMA Applications for Intra- 1993
Articular Prothetic Knee Ligament
Devices
----------------------------------------------------------------------------------------------------------------
Class II Special Controls Guidance June 3, 2003 Do. Do.
Document; Surgical Sutures; Guidance
for Industry and FDA
----------------------------------------------------------------------------------------------------------------
Guidance for Saline, Silicone Gel, and February 11, Do. Do.
Alternative Breast Implants; Guidance 2003
for Industry and FDA
----------------------------------------------------------------------------------------------------------------
Class II Special Controls Guidance October 22, Do. Do.
Document; Human Dura Mater; Draft 2002
Guidance for Industry and FDA
----------------------------------------------------------------------------------------------------------------
Guidance for Resorbable Adhesion June 18, 2002 Do. Do.
Barrier Devices for Use in Abdominal
and/or Pelvic Surgery; Guidance for
Industry
----------------------------------------------------------------------------------------------------------------
Guidance Document for Dura Substitute November 9, Do. Do.
Devices; Final Guidance for Industry 2000
----------------------------------------------------------------------------------------------------------------
Guidance for Neurological Embolization November 1, Do. Do.
Devices 2000
----------------------------------------------------------------------------------------------------------------
Guidance for the Preparation of a October 14, Do. Do.
Premarket Notification Application 1999
for Processed Human Dura Mater; Final
----------------------------------------------------------------------------------------------------------------
Guidance for Dermabrasion Devices; March 2, 1999 Do. Do.
Final
----------------------------------------------------------------------------------------------------------------
Guidance for the Preparation of a March 2, 1999 Do. Do.
Premarket Notification Application
for a Surgical Mesh; Final
----------------------------------------------------------------------------------------------------------------
Guidance for Content of Premarket April 28, 1998 Do. Do.
Notifications for Esophageal and
Tracheal Prostheses; Final
----------------------------------------------------------------------------------------------------------------
Guidance for Testing MR Interaction May 22, 1996 Do. Do.
With Aneurysm Clips
----------------------------------------------------------------------------------------------------------------
[[Page 875]]
Draft Guidance for the Preparation of April 4, 1995 Do. Do.
IDE Submission for Interactive Wound
and Burn Dressing
----------------------------------------------------------------------------------------------------------------
Draft Guidance for the Preparation of March 31, 1995 Do. Do.
a Premarket Notification for a Non-
Interactive Wound and Burn Dressing
----------------------------------------------------------------------------------------------------------------
Draft Version; Guidance on September 12, Do. Do.
Biocompatibility Requirements for 1994
Long Term Neurological Implants: Part
3--Implant Model
----------------------------------------------------------------------------------------------------------------
Protocol for Dermal Toxicity Testing January 1, 1985 Do. Do.
for Devices in Contact With Skin;
Draft
----------------------------------------------------------------------------------------------------------------
Class II Special Controls Guidance June 2, 2003 Do. Do.
Document; Resorbable Calcium Salt
Bone Void Filler Device; Guidance for
Industry and FDA
----------------------------------------------------------------------------------------------------------------
Guidance Document for Powered Muscle June 9, 1999 Do. Do.
Stimulator 510(k)s; Final
----------------------------------------------------------------------------------------------------------------
Guidance Document for the Preparation July 26, 1995 Do. Do.
of Notification (510(k)) Applications
for Therapeutic Massagers and
Vibrators
----------------------------------------------------------------------------------------------------------------
Guidance Document for the Preparation July 26, 1995 Do. Do.
of Premarket Notification (510(k))
Applications for Beds
----------------------------------------------------------------------------------------------------------------
Guidance Document for the Preparation July 26, 1995 Do. Do.
of Premarket Notification (510(k))
Applications for Communications
Systems (Powered and Nonpowered) and
Powered Environmental Control Systems
----------------------------------------------------------------------------------------------------------------
Guidance Document for the Preparation July 26, 1995 Do. Do.
of Premarket Notification (510(k))
Applications for Exercise Equipment
----------------------------------------------------------------------------------------------------------------
Guidance Document for the Preparation July 26, 1995 Do. Do.
of Premarket Notification (510(k))
Applications for Heating and Cooling
Devices
----------------------------------------------------------------------------------------------------------------
Guidance Document for the Preparation July 26, 1995 Do. Do.
of Premarket Notification (510(k))
Applications for Immersion Hydrobaths
----------------------------------------------------------------------------------------------------------------
Guidance Document for the Preparation July 26, 1995 Do. Do.
of Premarket Notification (510(k))
Applications for Powered Tables and
Multifunctional Physical Therapy
Tables
----------------------------------------------------------------------------------------------------------------
Guidance Document for the Preparation July 26, 1995 Do. Do.
of Premarket Notification (510(k))
Applications for Submerged
(Underwater) Exercise Equipment
----------------------------------------------------------------------------------------------------------------
Guidance Document for the Preparation July 26, 1995 Do. Do.
of Premarket Notification (510(k))
Applications for Mechanical and
Powered Wheelchairs, and Motorized
Three-Wheeled Vehicles
----------------------------------------------------------------------------------------------------------------
Guide for TENS 510(k) Content; Draft August 1, 1994 Do. Do.
----------------------------------------------------------------------------------------------------------------
Draft Version Guidance for Clinical August 20, 1992 Do. Do.
Data To Be Submitted for Premarket
Approval Application for Cranial
Electrotherapy Stimulators
----------------------------------------------------------------------------------------------------------------
Draft Guidance for Cortical Electrode August 10, 1992 Do. Do.
510(k) Content
----------------------------------------------------------------------------------------------------------------
Guidance for Studies for Pain Therapy May 12, 1988 Do. Do.
Devices--General Consideration in the
Design of Clinical Studies for Pain-
Alleviating Devices
----------------------------------------------------------------------------------------------------------------
[[Page 876]]
Accountability Analysis for Clinical August 4, 1999 Do. Do.
Studies for Ophthalmic Devices; Draft
----------------------------------------------------------------------------------------------------------------
Guidance Document for Nonprescription October 9, 1998 Do. Do.
Sunglasses; Final
----------------------------------------------------------------------------------------------------------------
Ophthalmoscope Guidance July 8, 1998 Do. Do.
----------------------------------------------------------------------------------------------------------------
Retinoscope Guidance; Final July 8, 1998 Do. Do.
----------------------------------------------------------------------------------------------------------------
Slit Lamp Guidance; Final July 8, 1998 Do. Do.
----------------------------------------------------------------------------------------------------------------
Discussion Points for Expansion of the September 5, Do. Do.
``Checklist of Information Usually 1997
Submitted in an Investigational
Device Exemption (IDE) Application
for Refractive Surgery Lasers;''
Draft Document
----------------------------------------------------------------------------------------------------------------
Third Party Review Guidance for January 31, Do. Do.
Phacofragmentation System Device 1997
Premarket Notification (510(k))
----------------------------------------------------------------------------------------------------------------
Third Party Review Guidance for January 31, Do. Do.
Vitreous Aspiration and Cutting 1997
Device Premarket Notification
(510(k))
----------------------------------------------------------------------------------------------------------------
Checklist of Information Usually October 10, Do. Do.
Submitted in an Investigational 1996
Device Exemptions (IDE) Application
for Refractive Surgery Lasers
(excimer)
----------------------------------------------------------------------------------------------------------------
Guidance for Manufacturers Seeking March 12, 2000 Do. Do.
Marketing Clearance of Ear, Nose, and
Throat Endoscope Sheaths Used as
Protective Barriers; Final
----------------------------------------------------------------------------------------------------------------
Tympanostomy Tubes, Submission January 14, Do. Do.
Guidance for a 510(k) Premarket 1998
Notification; Final
----------------------------------------------------------------------------------------------------------------
Guidance for the Arrangement and May 1, 1990 Do. Do.
Content of a Premarket Approval (PMA)
Application for a Cochlear Implant in
Children Ages 2 through 17 Years
----------------------------------------------------------------------------------------------------------------
Guideline for the Arrangement and May 1, 1990 Do. Do.
Content of a Premarket Approval (PMA)
Application for a Cochlear Implant in
Adults at Least 18 Years of Age
----------------------------------------------------------------------------------------------------------------
Refractive Implants: Guidance for August 1, 2000 Do. Do.
Investigational Device Exemptions
(IDE) and Premarket Approval (PMA)
Applications; Draft
----------------------------------------------------------------------------------------------------------------
Intraocular Lens Guidance Document; October 14, Do. Do.
Draft 1999
----------------------------------------------------------------------------------------------------------------
Guidance on 510(k) Submissions for March 3, 1999 Do. Do.
Keratoprostheses; Final
----------------------------------------------------------------------------------------------------------------
Aqueous Shunts--510(k) Submissions; November 16, Do. Do.
Final 1998
----------------------------------------------------------------------------------------------------------------
FDA Guidelines for Multifocal May 29, 1997 Do. Do.
Intraocular Lens IDE Studies and PMAs
----------------------------------------------------------------------------------------------------------------
Important Information About Rophae August 20, 1992 Do. Do.
Intraocular Lenses
----------------------------------------------------------------------------------------------------------------
Guidance for Premarket Submissions of April 10, 2000 Do. Do.
Orthokeratology Rigid Gas Permeable
Contact Lenses; Final
----------------------------------------------------------------------------------------------------------------
Revised Procedures for Adding Lens August 11, 1998 Do. Do.
Finishing Laboratories to Approved
Premarket Approval Applications for
Class III Rigid Gas Permeable Contact
Lenses for Extended Wear; Final
----------------------------------------------------------------------------------------------------------------
[[Page 877]]
Premarket Notification 510(k) Guidance May 1, 1997 Do. Do.
for Contact Lens Care Products
----------------------------------------------------------------------------------------------------------------
Premarket Notification (510(k)) June 28, 1994 Do. Do.
Guidance Document for Class II Daily
Wear Contact Lenses
----------------------------------------------------------------------------------------------------------------
New FDA Recommendations and Results of May 30, 1989 Do. Do.
Contact Lens Study (7-day letter)
----------------------------------------------------------------------------------------------------------------
Class II Special Controls Guidance November 28, Do. Do.
Document; Ingestible Telemetric 2001
Gastrointestinal Capsule Imaging
System; Final Guidance for Industry
and FDA
----------------------------------------------------------------------------------------------------------------
Class II Special Controls Guidance May 16, 2001 Do. Do.
Document; Tissue Culture Media for
Human Ex Vivo Tissue and Cell Culture
Processing Applications; Final
Guidance for Industry and FDA
Reviewers
----------------------------------------------------------------------------------------------------------------
Guidance for Investigational Device January 16, Do. Do.
Exemptions for Solutions for 2001
Hypothermic Flushing, Transport, and
Storage of Organs for
Transplantation; Final Guidance for
Industry and FDA Reviewers
----------------------------------------------------------------------------------------------------------------
Guidance for Industry and CDRH August 7, 1998 Do. Do.
Reviewers on the Content of Premarket
Notifications for Hemodialysis
Delivery Systems; Final
----------------------------------------------------------------------------------------------------------------
Guidance for the Content of Premarket August 7, 1998 Do. Do.
Notification for Conventional and
High Permeability Hemodialyzers;
Final
----------------------------------------------------------------------------------------------------------------
Guidance for the Content of Premarket February 5, Do. Do.
Notifications for Metal Expandable 1998
Biliary Stents; Final
----------------------------------------------------------------------------------------------------------------
Guidance for the Content of Premarket May 30, 1997 Do. Do.
Notifications for Water Purification
Components and Systems for
Hemodialysis
----------------------------------------------------------------------------------------------------------------
Draft Guidance for Hemodialyzer Reuse October 6, 1995 Do. Do.
Labeling
----------------------------------------------------------------------------------------------------------------
Class II Special Controls Guidance July 28, 2003 Do. Do.
Document; Breast Lesion Documentation
System; Guidance for Industry and FDA
Staff
----------------------------------------------------------------------------------------------------------------
Class II Special Controls Guidance for March 9, 2001 Do. Do.
Home Uterine Activity Monitors; Final
Guidance for Industry and FDA
Reviewers
----------------------------------------------------------------------------------------------------------------
Class II Special Controls Guidance July 3, 2000 Do. Do.
Document for Clitoral Engorgement
Devices
----------------------------------------------------------------------------------------------------------------
Draft Guidance for Industry; Electro- August 25, 1999 Do. Do.
optical Sensors for the In Vivo
Detection of Cervical Cancer and Its
Precursors: Submission Guidance for
an IDE/PMA
----------------------------------------------------------------------------------------------------------------
Devices Used for In Vitro September 10, Do. Do.
Fertilization and Related Assisted 1998
Reproduction Procedures; Draft
----------------------------------------------------------------------------------------------------------------
Latex Condoms for Men--Information for July 23, 1998 Do. Do.
510(k) Premarket Notifications: Use
of Consensus Standards for
Abbreviated Submissions
----------------------------------------------------------------------------------------------------------------
Uniform Contraceptive Labeling; Final July 23, 1998 Do. Do.
----------------------------------------------------------------------------------------------------------------
Intrapartum Continuous Monitors for June 14, 1997 Do. Do.
Fetal Oxygen Saturation and Fetal pH;
Submission Guidance for a PMA; Draft
Document
----------------------------------------------------------------------------------------------------------------
[[Page 878]]
Letter to Manufacturers of September 6, Do. Do.
Prescription Home Monitors for 1996
Nonstress Tests
----------------------------------------------------------------------------------------------------------------
Letter to Manufacturers of September 5, Do. Do.
Falloposcopes 1996
----------------------------------------------------------------------------------------------------------------
Thermal Endometrial Ablation Devices March 14, 1996 Do. Do.
(Submission Guidance for an IDE)
----------------------------------------------------------------------------------------------------------------
Hysteroscopes and Gynecology March 7, 1996 Do. Do.
Laparoscopes (Submission Guidance for
a 510(k))
----------------------------------------------------------------------------------------------------------------
Hysteroscopes and Laparoscopic August 1, 1995 Do. Do.
Insufflators (Submission Guidance for
a 510(k))
----------------------------------------------------------------------------------------------------------------
Testing Guidance for Male Condoms Made June 29, 1995 Do. Do.
From New Material (Nonlatex)
----------------------------------------------------------------------------------------------------------------
Draft Guidance for the Content of May 25, 1995 Do. Do.
Premarket Notifications for Menstrual
Tampons
----------------------------------------------------------------------------------------------------------------
Information for a Latex Condom 510(k) April 13, 1994 Do. Do.
Submission for Obstetrics-Gynecology
Devices Branch; Draft
----------------------------------------------------------------------------------------------------------------
Premarket Testing Guidelines for November 20, Do. Do.
Falloposcopes 1992
----------------------------------------------------------------------------------------------------------------
Draft Guidance for the Content of July 29, 1991 Do. Do.
Premarket Notifications for Loop and
Rollerball Electrodes for GYN
Electrosurgical Excisions
----------------------------------------------------------------------------------------------------------------
Premarket Testing Guidelines for April 4, 1990 Do. Do.
Female Barrier Contraceptive Devices
Also Intended to Prevent Sexually
Transmitted Diseases
----------------------------------------------------------------------------------------------------------------
Guidance (``Guidelines'') for May 10, 1978 Do. Do.
Evaluation of Hysteroscopic
Sterilization Devices
----------------------------------------------------------------------------------------------------------------
Guidance (``Guidelines'') for May 1, 1978 Do. Do.
Evaluation of Laparoscopic Bipolar
and Thermal Coagulators (and
Accessories)
----------------------------------------------------------------------------------------------------------------
Guidance (``Guidelines'') for November 22, Do. Do.
Evaluation of Tubal Occlusion Devices 1977
----------------------------------------------------------------------------------------------------------------
Guidance (``Guidelines'') for March 8, 1977 Do. Do.
Evaluation of Fetal Clip Electrode
----------------------------------------------------------------------------------------------------------------
Guidelines for Evaluation of Nondrug September 28, Do. Do.
IUDs 1976
----------------------------------------------------------------------------------------------------------------
Criteria for Significant Risk July 14, 2003 Do. Do.
Investigations of Magnetic Resonance
Diagnostic Devices; Guidance for
Industry and FDA Staff
----------------------------------------------------------------------------------------------------------------
Bone Sonometer PMA Applications; Final June 21, 2001 Do. Do.
Guidance for Industry and FDA
----------------------------------------------------------------------------------------------------------------
Premarket Applications for Digital February 16, Do. Do.
Mammography Systems; Final Guidance 2001
for Industry and FDA
----------------------------------------------------------------------------------------------------------------
Guidance for the Submission of August 2, 2000 Do. Do.
Premarket Notifications for Photon-
Emitting Brachytherapy Sources
----------------------------------------------------------------------------------------------------------------
Guidance for the Submission of July 27, 2000 Do. Do.
Premarket Notifications for Medical
Image Management Devices
----------------------------------------------------------------------------------------------------------------
Guidance for the Submission of 510(k)s August 6, 1999 Do. Do.
for Solid State X-ray Imaging
Devices; Final
----------------------------------------------------------------------------------------------------------------
[[Page 879]]
Guidance for the Submission of December 3, Do. Do.
Premarket Notifications for Emission 1998
Computed Tomography Devices and
Accessories (SPECT and PET) and
Nuclear Tomography Systems; Final
----------------------------------------------------------------------------------------------------------------
Guidance for the Submission of November 20, Do. Do.
Premarket Notifications for 1998
Radionuclide Dose Calibrators; Final
----------------------------------------------------------------------------------------------------------------
Harmonic Imaging With/Without November 16, Do. Do.
Contrast--Premarket Notification; 1998
Final
----------------------------------------------------------------------------------------------------------------
Guidance for the Submission of November 14, Do. Do.
Premarket Notifications for Magnetic 1998
Resonance Diagnostic Devices; Final
----------------------------------------------------------------------------------------------------------------
Information for Manufacturers Seeking September 30, Do. Do.
Marketing Clearance of Diagnostic 1997
Ultrasound Systems and Transducers
----------------------------------------------------------------------------------------------------------------
Letter: Notice to Manufacturers of September 25, Do. Do.
Bone Mineral Densitometers 1997
----------------------------------------------------------------------------------------------------------------
Simplified 510(k) Procedures for December 21, Do. Do.
Certain Radiology Devices: 12/21/93 1993
letter from L. Yin, ODE/DRAERD, to
NEMA
----------------------------------------------------------------------------------------------------------------
Draft Guidance for Review of Bone November 9, Do. Do.
Densitometer 510(k) Submissions 1992
----------------------------------------------------------------------------------------------------------------
Reviewer Guidance for Automatic X-Ray February 1, Do. Do.
Film Processor 510(k) 1990
----------------------------------------------------------------------------------------------------------------
Guidance for the Content of Premarket August 9, 2000 Do. Do.
Notifications (510(k)s) for
Extracorporeal Shock Wave
Lithotripters Indicated for the
Fragmentation of Kidney and Ureteral
Calculi
----------------------------------------------------------------------------------------------------------------
Guidance for the Content of Premarket January 16, Do. Do.
Notifications for Penile Rigidity 2000
Implants; Final
----------------------------------------------------------------------------------------------------------------
Guidance for the Content of Premarket November 30, Do. Do.
Notifications for Intracorporeal 1998
Lithotripters; Final
----------------------------------------------------------------------------------------------------------------
CDRH Interim Regulatory Policy for September 10, Do. Do.
External Penile Rigidity Devices 1997
----------------------------------------------------------------------------------------------------------------
Draft Guidance for Preclinical and November 29, Do. Do.
Clinical Investigations of Urethral 1995
Bulking Agents Used in the Treatment
of Urinary Incontinence
----------------------------------------------------------------------------------------------------------------
Draft Guidance for the Clinical November 2, Do. Do.
Investigation of Urethral Stents 1995
----------------------------------------------------------------------------------------------------------------
Draft 510(k) Checklist for Endoscopic August 16, 1995 Do. Do.
Electrosurgical Unit (ESU) and
Accessories Used in Gastroenterology
and Urology
----------------------------------------------------------------------------------------------------------------
Draft 510(k) Checklist for Urological August 1, 1995 Do. Do.
Irrigation System and Tubing Set
----------------------------------------------------------------------------------------------------------------
Draft 510(k) Checklist for Endoscopic June 22, 1995 Do. Do.
Light Sources Used in
Gastroenterology and Urology
----------------------------------------------------------------------------------------------------------------
Draft 510(k) Checklist for Non- June 6, 1995 Do. Do.
Implanted Electrical Stimulators Used
for the Treatment of Urinary
Incontinence
----------------------------------------------------------------------------------------------------------------
Draft Guidance for Preparation of PMA May 1, 1995 Do. Do.
Applications for the Implanted
Mechanical/Hydraulic Urinary
Continence Device (Artificial Urinary
Sphincter)
----------------------------------------------------------------------------------------------------------------
[[Page 880]]
Draft Guidance for the Content of March 17, 1995 Do. Do.
Premarket Notifications for
Endoscopes Used in Gastroenterology
and Urology
----------------------------------------------------------------------------------------------------------------
Draft 510(k) Checklist for Condom February 23, Do. Do.
Catheters 1995
----------------------------------------------------------------------------------------------------------------
Draft Guidance for Clinical November 11, Do. Do.
Investigations of Devices Used for 1994
the Treatment of Benign Prostatic
Hyperplasia (BPH)
----------------------------------------------------------------------------------------------------------------
Checklist for Mechanical Lithotripters November 1, Do. Do.
and Stone Dislodgers Used in 1994
Gastroenterology and Urology
----------------------------------------------------------------------------------------------------------------
510(k) Checklist for Sterile September 19, Do. Do.
Lubricating Jelly Used With 1994
Transurethral Surgical Instruments
----------------------------------------------------------------------------------------------------------------
Guidance for the Content of Premarket September 12, Do. Do.
Notifications for Conventional and 1994
Antimicrobial Foley Catheters
----------------------------------------------------------------------------------------------------------------
Guidance for the Content of Premarket July 29, 1994 Do. Do.
Notifications for Urodynamic/
Uroflowmetry Systems
----------------------------------------------------------------------------------------------------------------
Guidance for the Content of Premarket June 7, 1994 Do. Do.
Notifications for Urine Drainage Bags
----------------------------------------------------------------------------------------------------------------
Draft Guidance Outline--PTC for November 30, Do. Do.
Clinical Studies for Vasovasostomy 1993
Devices
----------------------------------------------------------------------------------------------------------------
Draft Guidance for Preparation of PMA March 16, 1993 Do. Do.
Applications for Penile Inflatable
Implants
----------------------------------------------------------------------------------------------------------------
Draft Guidance for Preparation of PMA March 16, 1993 Do. Do.
Applications for Testicular
Prostheses
----------------------------------------------------------------------------------------------------------------
Guidance for the Content of Premarket February 10, Do. Do.
Notifications for Biopsy Devices Used 1993
in Gastroenterology and Urology
----------------------------------------------------------------------------------------------------------------
Guidance for the Content of Premarket February 10, Do. Do.
Notifications for Ureteral Stents 1993
----------------------------------------------------------------------------------------------------------------
Draft Guidance for the Content of January 24, Do. Do.
Premarket Notifications for 1992
Urological Balloon Dilatation
Cathethers
----------------------------------------------------------------------------------------------------------------
Draft of Suggested Information for January 18, Do. Do.
Reporting Extracorporeal Shock Wave 1991
Lithotripsy Device Shock Wave
Measurements
----------------------------------------------------------------------------------------------------------------
Draft Guidance to Firms on Biliary August 2, 1990 Do. Do.
Lithotripsy Studies
----------------------------------------------------------------------------------------------------------------
Office of In Vitro Diagnostic Device Evaluation and Safety
----------------------------------------------------------------------------------------------------------------
Analyte Specific Reagents; Small February 26, Do. Do.
Entity Compliance Guidance; Guidance 2003
for Industry
----------------------------------------------------------------------------------------------------------------
Assessing the Safety/Effectiveness of October 1, 1988 Do. Do.
Home-Use In Vitro Diagnostic Devices
(IVDs): Draft PTC Regarding Labeling
and Premarket Submissions
----------------------------------------------------------------------------------------------------------------
Data for Commercialization of Original June 10, 1996 Do. Do.
Equipment Manufacturer, Secondary and
Generic Reagents for Automated
Analyzers
----------------------------------------------------------------------------------------------------------------
Determination of Intended Use for December 3, Do. Do.
510(k) Devices; Guidance for CDRH 2002
Staff
----------------------------------------------------------------------------------------------------------------
Guidance for Administrative Procedures August 14, 2000 Do. Do.
for CLIA Categorization
----------------------------------------------------------------------------------------------------------------
[[Page 881]]
Guidance for Clinical Laboratory March 1, 2001 Do. Do.
Improvement Amendments of 1988 (CLIA)
Criteria for Waiver; Draft Guidance
for Industry and FDA
----------------------------------------------------------------------------------------------------------------
Guidance for Industry; Abbreviated February 22, Do. Do.
510(k) Submissions for In Vitro 1999
Diagnostic Calibrators; Final
----------------------------------------------------------------------------------------------------------------
Guidance on Labeling for Laboratory June 24, 1999 Do. Do.
Tests; Draft
----------------------------------------------------------------------------------------------------------------
Letter to IVD Manufacturers on December 22, Do. Do.
Streamlined PMA; Final 1997
----------------------------------------------------------------------------------------------------------------
PTC for Collection of Data in Support September 26, Do. Do.
of In Vitro Device Submissions for 1994
510(k) Clearance
----------------------------------------------------------------------------------------------------------------
PTC for Review of Calibration and February 1, Do. Do.
Quality Control Labeling for In Vitro 1996
Diagnostic Devices (cover letter
dated March 14, 1996)
----------------------------------------------------------------------------------------------------------------
PTC Guidance Document on Assayed and February 3, Do. Do.
Unassayed Quality Control Material; 1999
Draft
----------------------------------------------------------------------------------------------------------------
Premarket Approval Application Filing May 1, 2003 Do. Do.
Review; Guidance for Industry and FDA
Staff
----------------------------------------------------------------------------------------------------------------
Breath Nitric Oxide Test System; Class July 7, 2003 Do. Do.
II Special Controls Guidance Document
----------------------------------------------------------------------------------------------------------------
Class II Special Control Guidance November 30, Do. Do.
Document for B-Type Natriuretic 2000
Peptide Premarket Notifications;
Final Guidance for Industry and FDA
Reviewers
----------------------------------------------------------------------------------------------------------------
Class II Special Controls Guidance September 16, Do. Do.
Document; Cyclosporine and Tacrolimus 2002
Assays; Guidance for Industry and FDA
----------------------------------------------------------------------------------------------------------------
Draft Guidance for Prescription Use of November 14, Do. Do.
Drugs of Abuse Assays Premarket 2000
Notifications
----------------------------------------------------------------------------------------------------------------
Draft Guidance on the Labeling for December 21, Do. Do.
Over-the-Counter Sample Collection 1999
Systems for Drugs of Abuse Testing
----------------------------------------------------------------------------------------------------------------
Guidance for 510(k)s on Cholesterol July 14, 1995 Do. Do.
Tests for Clinical Laboratory,
Physicians' Office Laboratory, and
Home Use
----------------------------------------------------------------------------------------------------------------
Guidance for Industry In Vitro July 6, 1998 Do. Do.
Diagnostic Bicarbonate/Carbon Dioxide
Test System; Final
----------------------------------------------------------------------------------------------------------------
Guidance for Industry In Vitro July 6, 1998 Do. Do.
Diagnostic Chloride Test System;
Final
----------------------------------------------------------------------------------------------------------------
Guidance for Industry In Vitro July 2, 1998 Do. Do.
Diagnostic Creatinine Test System;
Final
----------------------------------------------------------------------------------------------------------------
Guidance for Industry In Vitro July 6, 1998 Do. Do.
Diagnostic Glucose Test System; Final
----------------------------------------------------------------------------------------------------------------
Guidance for Industry In Vitro July 6, 1998 Do. Do.
Diagnostic Potassium Test System;
Final
----------------------------------------------------------------------------------------------------------------
Guidance for Industry In Vitro July 6, 1998 Do. Do.
Diagnostic Sodium Test System; Final
----------------------------------------------------------------------------------------------------------------
Guidance for Industry In Vitro July 6, 1998 Do. Do.
Diagnostic Urea Nitrogen Test System;
Final
----------------------------------------------------------------------------------------------------------------
Guidance for Industry; In Vitro July 20, 1998 Do. Do.
Diagnostic C-Reactive Protein
Immunological Test System
----------------------------------------------------------------------------------------------------------------
[[Page 882]]
Guidance for Over-the-Counter (OTC) July 22, 2000 Do. Do.
Human Chorionic Gonadotropin (hCG)
510(k)s
----------------------------------------------------------------------------------------------------------------
Guidance for Over-the-Counter (OTC) July 22, 2000 Do. Do.
Ovulation Predictor 510(k)s
----------------------------------------------------------------------------------------------------------------
Over-the-Counter (OTC) Screening Tests November 14, Do. Do.
for Drugs of Abuse; Guidance for 2000
Premarket Notifications
----------------------------------------------------------------------------------------------------------------
PTC for Portable Blood Glucose February 20, Do. Do.
Monitoring Devices Intended for 1996
Bedside Use in the Neonate Nursery
----------------------------------------------------------------------------------------------------------------
Review Criteria for Assessment of In August 31, 1995 Do. Do.
Vitro Diagnostic Devices for Drugs of
Abuse Assays Using Various
Methodologies
----------------------------------------------------------------------------------------------------------------
Review Criteria for Assessment of February 14, Do. Do.
Portable Blood Glucose In Vitro 1996
Diagnostic Devices Using Glucose
Oxidase, Dehydrogenase, or Hexokinase
Methodology
----------------------------------------------------------------------------------------------------------------
Review Criteria for Assessment of November 6, Do. Do.
Professional Use Human Chorionic 1996
Gonadotropin (hCG) In Vitro
Diagnostic Devices (IVDs)
----------------------------------------------------------------------------------------------------------------
510(k) Submissions for Coagulation June 19, 2003 Do. Do.
Instruments; Guidance for Industry
and FDA Staff
----------------------------------------------------------------------------------------------------------------
Class II Special Control Guidance August 23, 2000 Do. Do.
Document for Anti-Saccharomyces
cerevisia (S. cerevisiae) Antibody
(ASCA) Premarket Notifications
----------------------------------------------------------------------------------------------------------------
Class II Special Controls Guidance December 4, Do. Do.
Document: Premarket Notifications for 2001
Automated Differential Cell Counters
for Immature or Abnormal Blood Cells;
Final Guidance for Industry and FDA
----------------------------------------------------------------------------------------------------------------
Document for Special Controls for April 28, 1999 Do. Do.
Erythropoietin Assay Premarket
Notifications (510(k)s); Final
----------------------------------------------------------------------------------------------------------------
Draft Guidance Document for 510(k) July 29, 1992 Do. Do.
Submission of Fecal Occult Blood
Tests
----------------------------------------------------------------------------------------------------------------
Draft Guidance Document for 510(k) September 30, Do. Do.
Submission of Glycohemoglobin 1991
(Glycated or Glycosylated) Hemoglobin
for IVDs
----------------------------------------------------------------------------------------------------------------
Draft Guidance Document for 510(k) September 1, Do. Do.
Submission of Immunoglobulins A, G, 1992
M, D and E Immunoglobulin System In
Vitro Devices
----------------------------------------------------------------------------------------------------------------
Draft Guidance for 510(k) Submission September 26, Do. Do.
of Lymphocyte Immunophenotyping IVDs 1991
Using Monoclonal Antibodies
----------------------------------------------------------------------------------------------------------------
Draft; Premarketing Approval Review September 10, Do. Do.
Criteria for Premarket Approval of 1992
Estrogen (ER) or Progesterone (PGR)
Receptors In Vitro Diagnostic Devices
Using Steroid Hormone Binding (SBA)
with Dextran-Coated Charcoal (DCC)
Separation, Histochemical Receptor
Bind
----------------------------------------------------------------------------------------------------------------
Guidance Document for the Submission September 19, Do. Do.
of Tumor Associated Antigen Premarket 1996
Notification (510(k)) to FDA
----------------------------------------------------------------------------------------------------------------
Guidance for Submission of June 3, 1998 Do. Do.
Immunohistochemistry Applications to
the FDA; Final
----------------------------------------------------------------------------------------------------------------
In Vitro Diagnostic Fibrin Monomer April 27, 1999 Do. Do.
Paracoagulation Test; Final
----------------------------------------------------------------------------------------------------------------
[[Page 883]]
Multiplex Tests for Heritable DNA February 27, Do. Do.
Markers, Mutations, and Expression 2003
Patterns; Draft Guidance for Industry
and FDA Reviewers
----------------------------------------------------------------------------------------------------------------
PTC for Cervical Cytology Devices July 25, 1994 Do. Do.
----------------------------------------------------------------------------------------------------------------
PTC for Hematology Quality Control September 30, Do. Do.
Materials 1997
----------------------------------------------------------------------------------------------------------------
Radioallergosorbent Test (RAST) August 22, 2001 Do. Do.
Methods for Allergen-Specific
Immunoglobulin E (IgE) 510(k)s; Final
Guidance for Industry and FDA
----------------------------------------------------------------------------------------------------------------
Review Criteria for Assessment of July 15, 1994 Do. Do.
Alpha-Fetoprotein (AFP) In Vitro
Diagnostic Devices for Fetal Open
Neural Tube Defects Using
Immunological Test Methodologies
----------------------------------------------------------------------------------------------------------------
Review Criteria for Assessment of July 15, 1991 Do. Do.
Cytogenetic Analysis Using Automated
and Semi-Automated Chromosome
Analyzers
----------------------------------------------------------------------------------------------------------------
Review Criteria for Assessment of February 21, Do. Do.
Rheumatoid Factor (RF) In Vitro 1997
Diagnostic Devices Using Enzyme-
Linked Immunoassay (EIA), Enzyme
Linked Immunosorbent Assay (ELISA),
Particle Agglutination Tests, and
Laser and Rate Nephelometry
----------------------------------------------------------------------------------------------------------------
Review Criteria for Blood Culture August 12, 1991 Do. Do.
Systems
----------------------------------------------------------------------------------------------------------------
Review Criteria for In Vitro August 1, 1992 Do. Do.
Diagnostic Devices for Detection of
IGM Do Antibodies to Viral Agents
----------------------------------------------------------------------------------------------------------------
Review Criteria for In Vitro February 1, Do. Do.
Diagnostic Devices for the Assessment 1994
of Thyroid Autoantibodies Using
Indirect Immunofluorescence Assay
(IFA), Indirect Hemagglutination
Assay (IHA), Radioimmunoasay (RIA),
and Enzyme Linked Immunosorbent Assay
(ELISA)
----------------------------------------------------------------------------------------------------------------
Review Criteria for In Vitro February 15, Do. Do.
Diagnostic Devices That Utilize 1996
Cytogenetic In Situ Hybridization
Technology for the Detection of Human
Genetic Mutations (Germ Line and
Somatic)
----------------------------------------------------------------------------------------------------------------
Review Criteria for the Assessment of September 1, Do. Do.
Anti-Nuclear Antibodies (ANA) In 1992
Vitro Diagnostic Devices Using
Indirect Immunofluorescence Assay
(IFA), Immunodiffusion (IMD), and
Enzyme Linked Immunosorbant Assay
(ELISA)
----------------------------------------------------------------------------------------------------------------
Class II Special Controls Guidance February 5, Do. Do.
Document; Antimicrobial 2003
Susceptibility Test (AST) Systems;
Guidance for Industry and FDA
----------------------------------------------------------------------------------------------------------------
Draft Review Criteria for Nucleic Acid June 14, 1993 Do. Do.
Amplification Based In Vitro
Diagnostic Devices for Direct
Detection of Infectious
Microorganisms
----------------------------------------------------------------------------------------------------------------
Premarket Approval Applications for In April 27, 2001 Do. Do.
Vitro Diagnostic Devices Pertaining
to Hepatitis C Viruses (HCV): Assays
Intended for Diagnosis, Prognosis, or
Monitoring of HCV Infection,
Hepatitis C, or Other HCV-Associated
Disease; Draft Guidance for Industry
and FDA
----------------------------------------------------------------------------------------------------------------
Review Criteria for Assessment of October 30, Do. Do.
Antimicrobial Susceptibility Test 1996
Discs
----------------------------------------------------------------------------------------------------------------
[[Page 884]]
Review Criteria for Assessment of In January 1, 1992 Do. Do.
Vitro Diagnostic Devices for Direct
Detection of Chlamydiae in Clinical
Specimens
----------------------------------------------------------------------------------------------------------------
Review Criteria for Assessment of In July 6, 1993 Do. Do.
Vitro Diagnostic Devices for Direct
Detection of Mycobacterium Spp.
(Tuberculosis (TB))
----------------------------------------------------------------------------------------------------------------
Review Criteria for Assessment of September 17, Do. Do.
Laboratory Tests for the Detection of 1992
Antibodies to Helicobacter pylori
----------------------------------------------------------------------------------------------------------------
Review Criteria for Devices Assisting May 31, 1990 Do. Do.
in the Diagnosis of C. Difficile
Associated Diseases
----------------------------------------------------------------------------------------------------------------
Review Criteria for Devices Intended December 30, Do. Do.
for the Detection of Hepatitis B `e' 1991
Antigen and Antibody to HBe
----------------------------------------------------------------------------------------------------------------
Review Criteria for Premarket Approval May 15, 1992 Do. Do.
of In Vitro Diagnostic Devices for
Detection of Antibodies to Parvovirus
B19
----------------------------------------------------------------------------------------------------------------
Office of Surveillance and Biometrics
----------------------------------------------------------------------------------------------------------------
PMA Review Statistical Checklist (no date Do. Do.
available)
----------------------------------------------------------------------------------------------------------------
Statistical Aspects of Submissions to June 1, 1984 Do. Do.
FDA: A Medical Device Perspective
(also includes as appendix the
article ``Observed Uses and Abuses of
Statistical Procedures in Medical
Device Submissions'')
----------------------------------------------------------------------------------------------------------------
Statistical Guidance for Clinical January 1, 1996 Do. Do.
Trials of Nondiagnostic Medical
Devices
----------------------------------------------------------------------------------------------------------------
MDR Guidance Document: Remedial Action September 26, Industry and FDA Do.
Exemption; Final 2001
----------------------------------------------------------------------------------------------------------------
Guidance on Adverse Event Reporting April 24, 2001 Industry Do.
for Hospitals That Reprocess Devices
Intended by the Original Equipment
Manufacturer for Single Use
----------------------------------------------------------------------------------------------------------------
MDR Guidance Document No. 1--IOL-- August 7, 1996 Do. Do.
E1996004; Final
----------------------------------------------------------------------------------------------------------------
Common Problems: Baseline Reports and January 1, 1997 Do. Do.
Medwatch Form 3500A
----------------------------------------------------------------------------------------------------------------
Medical Device Reporting: An Overview; April 1, 1996 Do. Do.
Final
----------------------------------------------------------------------------------------------------------------
Instructions for Completing FDA Form December 15, Do. Do.
3500A With Coding Manual for Form 1995
3500A (MEDWATCH) (MDR); Final
----------------------------------------------------------------------------------------------------------------
MEDWATCH FDA Form 3500A for Use by June 1, 1993 Industry and user facilities Do.
User Facilities, Distributors and
Manufacturers for Mandatory Reporting
(MDR); Final
----------------------------------------------------------------------------------------------------------------
Variance from Manufacturer Report July 16, 1996 Industry Do.
Number Format (MDR letter); Final
----------------------------------------------------------------------------------------------------------------
Instructions for Completing Form 3417: March 31, 1997 Do. Do.
Medical Device Reporting Baseline
Report (MDR); Final
----------------------------------------------------------------------------------------------------------------
Medical Device Reporting--Alternative October 19, Do. Do.
Summary Reporting (ASR) Program; 2000
Guidance for Industry
----------------------------------------------------------------------------------------------------------------
Addendum to the Instructions for June 9, 1999 Do. Do.
Completing FDA Form 3500A With Coding
Manual (MEDWATCH) (MDR); Final
----------------------------------------------------------------------------------------------------------------
[[Page 885]]
Needlesticks--Medical Device Reporting November 12, Industry and user facilities Do.
Guidance 2002
----------------------------------------------------------------------------------------------------------------
Guidance to Sponsors on the June 9, 1993 Industry and FDA reviewers Do.
Development of a Discretionary
Postmarket Surveillance Study for
Permanent Implantable Cardiac
Pacemaker Electrodes (Leads)
----------------------------------------------------------------------------------------------------------------
Guidance on Criteria and Approaches November 2, Do. Do.
for Postmarket Surveillance 1998
----------------------------------------------------------------------------------------------------------------
Guidance on Procedures to Determine February 19, FDA reviewers Do.
Application of Postmarket 1998
Surveillance Strategies (FDAMA);
Final
----------------------------------------------------------------------------------------------------------------
Guidance on Procedures for Review of February 19, Do. Do.
Postmarket Surveillance Submissions 1998
(FDAMA); Final
----------------------------------------------------------------------------------------------------------------
Guidance for Industry and FDA Staff; November 2, Industry and FDA reviewers Do.
SMDA to FDAMA: Guidance on FDA's 1998
Transition Plan for Existing
Postmarket Surveillance Protocols
(FDAMA); Final
----------------------------------------------------------------------------------------------------------------
Amendment to Guidance on Discretionary March 30, 1994 Do. Do.
Postmarket Surveillance on Pacemaker
Leads; Final
----------------------------------------------------------------------------------------------------------------
Guidance for Industry on the Testing February 2, Do. Do.
of Metallic Plasma Sprayed Coatings 2000
on Orthopedic Implants to Support
Reconsideration of Postmarket
----------------------------------------------------------------------------------------------------------------
Office of Compliance
----------------------------------------------------------------------------------------------------------------
Commercial Distribution/Exhibit Letter March 11, 1992 Do. Do.
----------------------------------------------------------------------------------------------------------------
FDA Guide for Validation of Biological January 1, 1986 Do. Do.
Indicator Incubation Time
----------------------------------------------------------------------------------------------------------------
Guide for Establishing and Maintaining March 1, 1988 Do. Do.
a Calibration Constancy
Intercomparison System for Microwave
Oven Compliance Survey Instruments
(FDA 88-8264)
----------------------------------------------------------------------------------------------------------------
General Principles of Software January 11, Do. Do.
Validation; Draft Guidance 2002
----------------------------------------------------------------------------------------------------------------
Guidance on Medical Device Tracking May 23, 2003 Do. Do.
(FDAMA); Guidance for Industry and
FDA Staff
----------------------------------------------------------------------------------------------------------------
Compliance Program Guidance Manual: February 7, Do. Do.
Inspection of Medical Devices; Draft 2001
----------------------------------------------------------------------------------------------------------------
Procedures for Laboratory Compliance May 1, 1986 Do. Do.
Testing of Television Revivers--Part
of TV Packet
----------------------------------------------------------------------------------------------------------------
Guidance on Quality System Regulation February 3, Do. Do.
Information for Various Premarket 2003
Submissions; Draft
----------------------------------------------------------------------------------------------------------------
Surveillance and Detention Without July 26, 2000 Do. Do.
Physical Examination of Surgeons' and/
or Patient Examination Gloves;
Guidance for Industry
----------------------------------------------------------------------------------------------------------------
Manufacturers/Assemblers of Diagnostic October 13, Do. Do.
X-Ray Systems: Enforcement Policy for 1993
Positive-Beam Limitation (PBL)
Requirements in 21 CFR 1020.31(g)
----------------------------------------------------------------------------------------------------------------
Guidance for the Submission of Initial January 1, 1982 Do. Do.
Reports on Diagnostic X-Ray Systems
and Their Major Components
----------------------------------------------------------------------------------------------------------------
[[Page 886]]
Exemption From Reporting and September 16, Do. Do.
Recordkeeping Requirements for 1981
Certain Sunlamp Product Manufacturers
----------------------------------------------------------------------------------------------------------------
Letter to Medical Device Industry on May 17, 1993 Do. Do.
Endoscopy and Laparoscopy Accessories
(Galdi)
----------------------------------------------------------------------------------------------------------------
Clarification of Radiation Control March 1, 1989 Do. Do.
Regulations for Diagnostic X-Ray
Equipment (FDA 89-8221)
----------------------------------------------------------------------------------------------------------------
CPG 7133.19: Retention of Microwave March 1, 1995 Do. Do.
Oven Test Record/Cover Letter: August
24, 1981; Retention of Records
Required by 21 CFR 1002
----------------------------------------------------------------------------------------------------------------
A Guidance for the Submission of March 1, 1996 Do. Do.
Abbreviated Radiation Safety Reports
on Cephalometric X-Ray Devices:
Defined as Dental Units With an
Attachment for Mandible Work That
Holds a Cassette and Beam Limiting
Device
----------------------------------------------------------------------------------------------------------------
A Guide for the Submission of an March 1, 1996 Do. Do.
Abbreviated Radiation Safety Report
on X-Ray Tables, Cradles, Film
Changers or Cassette Holders Intended
for Diagnostic Use
----------------------------------------------------------------------------------------------------------------
A Guide for the Submission of March 1, 1996 Do. Do.
Abbreviated Radiation Safety Reports
on Image Receptor Support Devices for
Mammography X-Ray Systems
----------------------------------------------------------------------------------------------------------------
Compliance Program Guidance Manual; March 15, 2000 Do. Do.
Field Compliance Testing of
Diagnostic (Medical) X-Ray Equipment;
Guidance for FDA Staff
----------------------------------------------------------------------------------------------------------------
Information Disclosure by April 2, 2001 Do. Do.
Manufacturers to Assemblers for
Diagnostic X-Ray Systems; Final
Guidance for Industry and FDA
----------------------------------------------------------------------------------------------------------------
Guide for Submission of Information on April 1, 1971 Do. Do.
Accelerators Intended to Emit X-
Radiation Required Pursuant to 21 CFR
1002.10
----------------------------------------------------------------------------------------------------------------
Abbreviated Report on Radiation Safety August 1, 1995 Do. Do.
for Microwave Products (Other Than
Microwave Ovens)--e.g., Microwave
Heating, Microwave Diathermy, RF
Sealers, Induction, Dielectric
Heaters, Security Systems
----------------------------------------------------------------------------------------------------------------
Guide for Preparing Reports on March 1, 1985 Do. Do.
Radiation Safety of Microwave Ovens
----------------------------------------------------------------------------------------------------------------
Reporting Guide for Laser Light Shows September 1, Do. Do.
and Displays (21 CFR 1002) (FDA 88- 1995
8140)
----------------------------------------------------------------------------------------------------------------
Guide for Filing Annual Reports for X- July 1, 1980 Do. Do.
Ray Components and Systems
----------------------------------------------------------------------------------------------------------------
Reporting and Compliance Guide for October 1, 1995 Do. Do.
Television Products Including Product
Report, Supplemental Report,
Radiation Safety Abbreviated Report,
Annual Report, Information, and
Guidance
----------------------------------------------------------------------------------------------------------------
Revised Guide for Preparing Annual September 1, Do. Do.
Reports on Radiation Safety Testing 1995
of Laser and Laser Light Show
Products (replaces FDA 82-8127)
----------------------------------------------------------------------------------------------------------------
Guide for Preparing Abbreviated September 1, Do. Do.
Reports of Microwave and RF Emitting 1996
Electronic Products Intended for
Medical Use
----------------------------------------------------------------------------------------------------------------
[[Page 887]]
Letter to Manufacturers and Importers October 31, Do. Do.
of Microwave Ovens: Information 1988
Requirements for Cookbooks and User
and Service Manuals
----------------------------------------------------------------------------------------------------------------
Abbreviated Report on Radiation Safety August 1, 1995 Do. Do.
of Nonmedical Ultrasonic Products
----------------------------------------------------------------------------------------------------------------
Guide for Preparing Product Reports September 1, Do. Do.
for Medical Ultrasound Products 1996
----------------------------------------------------------------------------------------------------------------
Letter to Manufacturers, Distributors, February 23, Do. Do.
and Importers of Condom Products 1994
----------------------------------------------------------------------------------------------------------------
Letter to Manufacturers, Importers, February 13, Do. Do.
and Repackagers of Condoms for 1989
Contraception or Sexually-Transmitted
Disease Prevention (Holt)
----------------------------------------------------------------------------------------------------------------
Letter to Condom Manufacturers and April 5, 1994 Do. Do.
Distributors
----------------------------------------------------------------------------------------------------------------
Letter to Manufacturers/Repackers April 22, 1994 Do. Do.
Using Cotton
----------------------------------------------------------------------------------------------------------------
Guide for Preparing Product Reports September 1, Do. Do.
for Lasers and Products Containing 1995
Lasers
----------------------------------------------------------------------------------------------------------------
Compliance Guide for Laser Products September 1, Do. Do.
(FDA 86-8260) 1985
----------------------------------------------------------------------------------------------------------------
Condoms: Inspection and Sampling at April 8, 1987 Do. Do.
Domestic Manufacturers and of All
Repackers; Sampling From All
Importers (Damaska memo to field on
April 8, 1987)
----------------------------------------------------------------------------------------------------------------
Dental Hand Piece Sterilization (dear September 28, Do. Do.
doctor letter) 1992
----------------------------------------------------------------------------------------------------------------
Latex Labeling Letter (Johnson) March 18, 1993 Do. Do.
----------------------------------------------------------------------------------------------------------------
Pesticide Regulation Notice 94-4: June 30, 1994 Do. Do.
Interim Measures for the Registration
of Antimicrobial Products/Liquid
Chemical Germicides With Medical
Device Use Claims Under the
Memorandum of Understanding Between
EPA and FDA
----------------------------------------------------------------------------------------------------------------
Letter to Industry, Powered Wheelchair May 10, 1993 Do. Do.
Manufacturers, from RM Johnson
----------------------------------------------------------------------------------------------------------------
Hazards of Volume Ventilators and September 15, Do. Do.
Heated Humidifiers 1993
----------------------------------------------------------------------------------------------------------------
Manufacturers and Initial Distributors February 3, Do. Do.
of Sharps Containers and Destroyers 1994
Used by Health Care Professionals
----------------------------------------------------------------------------------------------------------------
Ethylene Oxide; Ethylene Chlorohydrin; June 23, 1978 Do. Do.
and Ethylene Glycol: Proposed Maximum
Residue Limits and Maximum Levels of
Exposure
----------------------------------------------------------------------------------------------------------------
Letter to Manufacturers and Users of October 10, Do. Do.
Lasers for Refractive Surgery 1996
(excimer)
----------------------------------------------------------------------------------------------------------------
Shielded Trocars and Needles Used for August 23, 1996 Do. Do.
Abdominal Access During Laparoscopy
----------------------------------------------------------------------------------------------------------------
Surveillance and Detention Without August 14, 2000 Do. Do.
Physical Examination of Condoms;
Draft Guidance for Industry
----------------------------------------------------------------------------------------------------------------
All U.S. Condom Manufacturers, April 7, 1987 Do. Do.
Importers, and Repackagers
----------------------------------------------------------------------------------------------------------------
Manufacturers and Initial Distributors May 23, 1996 Do. Do.
of Hemodialyzers
----------------------------------------------------------------------------------------------------------------
[[Page 888]]
Laser Light Show Safety--Who's May 1, 1986 Do. Do.
Responsible? (FDA 86-8262)
----------------------------------------------------------------------------------------------------------------
Suggested State Regulations for January 1, 1982 Do. Do.
Control of Radiation; Volume II;
Nonionizing Radiation--Lasers (FDA
Pub. No. 83-8220)
----------------------------------------------------------------------------------------------------------------
Letter to All Foreign Manufacturers May 28, 1981 Do. Do.
and Importers of Electronic Products
For Which Applicable FDA Performance
Standards Exist
----------------------------------------------------------------------------------------------------------------
Guide for Submission of Information on March 1, 1973 Do. Do.
Industrial X-Ray Equipment Required
Pursuant to 21 CFR 1002.10
----------------------------------------------------------------------------------------------------------------
Guide for Submission of Information on April 30, 1974 Do. Do.
Analytical X-Ray Equipment Required
Pursuant to 21 CFR 1002.10
----------------------------------------------------------------------------------------------------------------
Guidance for the Submission of Cabinet February 1, Do. Do.
X-Ray System Reports Pursuant to 21 1975
CFR 1020.40
----------------------------------------------------------------------------------------------------------------
Guide for Preparing Annual Reports in October 1, 1987 Do. Do.
Radiation Safety Testing of
Electronic Products (General)
----------------------------------------------------------------------------------------------------------------
Computerized Devices/Processes May 1, 1992 Do. Do.
Guidance--Application of the Medical
Device GMP to Computerized Devices
and Manufacturing Processes
----------------------------------------------------------------------------------------------------------------
Guide for Preparing Product Reports August 1, 1996 Do. Do.
for Ultrasonic Therapy Products
(Physical Therapy Only)
----------------------------------------------------------------------------------------------------------------
Guide for Submission of Information on November 1, Do. Do.
Industrial Radiofrequency Dielectric 1980
Heater and Sealer Equipment Pursuant
to 21 CFR 1002.10 and 1002.12 (FDA 81-
8137)
----------------------------------------------------------------------------------------------------------------
Guide for Preparing Annual Reports for September 1, Do. Do.
Ultrasonic Therapy Products 1996
----------------------------------------------------------------------------------------------------------------
Guide for Preparing Annual Reports on September 1, Do. Do.
Radiation Safety Testing of Sunlamps 1995
and Sunlamp Products (replaces FDA 82-
8127)
----------------------------------------------------------------------------------------------------------------
Guide for Preparing Annual Reports on September 1, Do. Do.
Radiation Safety Testing of Mercury 1995
Vapor (replaces FDA 82-8127)
----------------------------------------------------------------------------------------------------------------
Quality Control Guide for Sunlamp September 1, Do. Do.
Products (FDA 88-8234) 1984
----------------------------------------------------------------------------------------------------------------
Guide for the Submission of Initial December 1, Do. Do.
Reports on Computed Tomography X-Ray 1985
Systems
----------------------------------------------------------------------------------------------------------------
Guide for Preparing Product Reports on September 1, Do. Do.
Sunlamps and Sunlamp Products (21 CFR 1995
1002)
----------------------------------------------------------------------------------------------------------------
Letter: Policy on Maximum Timer June 25, 1985 Do. Do.
Interval and Exposure Schedule for
Sunlamp Products
----------------------------------------------------------------------------------------------------------------
Reporting Guide for Product Reports on September 1, Do. Do.
High Intensity Mercury Vapor 1995
Discharge Lamps (21 CFR 1002)
----------------------------------------------------------------------------------------------------------------
Quality Control Practices for May 1, 1980 Do. Do.
Compliance With the Federal Mercury
Vapor Lamp Performance Standard
----------------------------------------------------------------------------------------------------------------
Keeping Up With the Microwave March 1, 1990 Do. Do.
Revolution (FDA Publication No. 91-
4160)
----------------------------------------------------------------------------------------------------------------
[[Page 889]]
Quality Assurance Guidelines for February 1, Do. Do.
Hemodialysis Devices 1991
----------------------------------------------------------------------------------------------------------------
Letter to Manufacturers and Importers March 28, 1980 Do. Do.
of Microwave Ovens--Open Door
Operation of Microwave Ovens as a
Result of Oven Miswiring
----------------------------------------------------------------------------------------------------------------
Reporting of New Model Numbers to June 14, 1983 Do. Do.
Existing Model Families
----------------------------------------------------------------------------------------------------------------
Import: Radiation-Producing Electronic November 1, Do. Do.
Products (FDA 89-8008) 1988
----------------------------------------------------------------------------------------------------------------
Unsafe Patient Lead Wires and Cables September 3, Do. Do.
1993
----------------------------------------------------------------------------------------------------------------
Application of a Variance From 21 CFR July 1, 1998 Do. Do.
1040.11(c) for a Laser Light Show,
Display, or Device (form FDA 3147)
----------------------------------------------------------------------------------------------------------------
Letter to Trade Association: Reuse of December 27, Do. Do.
Single-Use or Disposable Medical 1995
Devices
----------------------------------------------------------------------------------------------------------------
Design Control Guidance for Medical March 11, 1997 Do. Do.
Device Manufacturers
----------------------------------------------------------------------------------------------------------------
Keeping Medical Devices Safe from July 1, 1995 Do. Do.
Electromagnetic Interference
----------------------------------------------------------------------------------------------------------------
Safety of Electrically Powered September 18, Do. Do.
Products: Letter to Medical Devices 1996
and Electronic Products Manufacturers
from Lilliam Gill and BHB Correction
Memo
----------------------------------------------------------------------------------------------------------------
Enforcement Priorities for Single-Use August 14, 2000 Do. Do.
Devices Reprocessed by Third Parties
and Hospitals; Guidance for Industry
and for FDA Staff
----------------------------------------------------------------------------------------------------------------
Labeling for Electronic Anti-theft August 15, 2000 Do. Do.
Systems; Final Guidance for Industry
----------------------------------------------------------------------------------------------------------------
Wireless Medical Telemetry Risks and September 27, Do. Do.
Recommendations; Final Guidance for 2000
Industry
----------------------------------------------------------------------------------------------------------------
Policy on Warning Label Required on June 25, 1985 Do. Do.
Sunlamp Products
----------------------------------------------------------------------------------------------------------------
Policy on Lamp Compatibility September 2, Do. Do.
(Sunlamps) 1986
----------------------------------------------------------------------------------------------------------------
Office of Science and Technology
----------------------------------------------------------------------------------------------------------------
Guidance on Frequently Asked Questions December 21, Do. Do.
on Recognition of Consensus Standards 1998
(FDAMA)
----------------------------------------------------------------------------------------------------------------
Guidance on the Recognition and Use of February 19, Do. Do.
Consensus Standards; appendix A 1998
(FDAMA)
----------------------------------------------------------------------------------------------------------------
CDRH Standard Operating Procedures for August 6, 1999 Do. Do.
the Identification and Evaluation of
Candidate Consensus Standard for
Recognition
----------------------------------------------------------------------------------------------------------------
Guidance for Industry and FDA May 6, 1999 Do. Do.
Reviewers: Guidance on Immunotoxicity
Testing
¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤
WITHDRAWN GUIDANCES
----------------------------------------------------------------------------------------------------------------
Medical Devices Made With September 6, N/A N/A
Polyvinylchloride (PVC) Using the 2002
Plasticizer di-(2-
Ethylhexyl)phthalate (DEHP); Draft
Guidance for Industry and FDA
----------------------------------------------------------------------------------------------------------------
[[Page 890]]
Draft Guidance on Evidence Models for September 1, Do. Do.
the Least Burdensome Means to Market 1999
----------------------------------------------------------------------------------------------------------------
Modifications to Devices Subject to August 6, 1998 Do. Do.
Premarket Approval--The PMA
Supplement Decision Making Process;
Draft
----------------------------------------------------------------------------------------------------------------
Guidance for Industry; Contents of a July 27, 1998 Do. Do.
Product Development Protocol; Draft
----------------------------------------------------------------------------------------------------------------
New Model Medical Device Development July 21, 1998 Do. Do.
Process; Final
----------------------------------------------------------------------------------------------------------------
Document Review by the Office of the June 6, 1999 Do. Do.
Chief Counsel (blue book memo G96-1)
----------------------------------------------------------------------------------------------------------------
Letter: Vascular Graft Industry November 22, Do. Do.
(Philip Phillips) 1995
----------------------------------------------------------------------------------------------------------------
Color Additives for Medical Devices November 15, Do. Do.
(Snesko) 1995
----------------------------------------------------------------------------------------------------------------
PMA/510(k) Triage Review Procedures May 20, 1994 Do. Do.
(blue book memo G94-1)
----------------------------------------------------------------------------------------------------------------
Proposal for Establishing Mechanisms June 30, 1993 Do. Do.
for Setting Review Priorities Using
Risk Assessment and Allocating Review
Resources
----------------------------------------------------------------------------------------------------------------
4-of-a-Kind PMAs October 1, 1999 Do. Do.
----------------------------------------------------------------------------------------------------------------
Review of 510(k)s for Computer August 29, 1991 Do. Do.
Controlled Medical Devices (blue book
memo K91-1)
----------------------------------------------------------------------------------------------------------------
Review of Final Draft Medical Device August 29, 1991 Do. Do.
Labeling (blue book memo P91-
4)
----------------------------------------------------------------------------------------------------------------
Clinical Utility and Premarket May 3, 1991 Do. Do.
Approval (blue book memo P91-
1)
----------------------------------------------------------------------------------------------------------------
Review and Approval of PMAs of October 22, Do. Do.
Licensees (blue book memo < greek- 1990
i>P86-4)
----------------------------------------------------------------------------------------------------------------
PMA Supplements: ODEs Letter to April 24, 1990 Do. Do.
Manufacturers; Identifies Situation
Which May Require the Submission of a
PMA Supplement (blue book memo < greek-
i>P90-1)
----------------------------------------------------------------------------------------------------------------
FDA Policy for the Regulation of November 13, Do. Do.
Computer Products; Draft 1989
----------------------------------------------------------------------------------------------------------------
PMA Review Schedules (P87-1) (replaced March 31, 1988 Do. Do.
by P94-2)
----------------------------------------------------------------------------------------------------------------
Necessary Information for Diagnostic November 24, Do. Do.
Ultrasound 510(k); Draft 1987
----------------------------------------------------------------------------------------------------------------
Guideline on Sterile Drug Products June 1, 1987 Do. Do.
Produced by Aseptic Processing
----------------------------------------------------------------------------------------------------------------
ODE Regulatory Information for the May 15, 1987 Do. Do.
Office of Compliance; Information
Sharing Procedures (blue book memo
G87-2)
----------------------------------------------------------------------------------------------------------------
Panel Review of ``Me-Too'' Devices July 1, 1986 Do. Do.
(blue book memo P86-6)
----------------------------------------------------------------------------------------------------------------
Criteria for Panel Review of PMA January 30, Do. Do.
Supplements (blue book memo < greek- 1986
i>P86-3)
----------------------------------------------------------------------------------------------------------------
[[Page 891]]
PMAs-Early Review and Preparation of January 27, Do. Do.
Summaries of Safety and Effectiveness 1986
(blue book memo P86-1)
----------------------------------------------------------------------------------------------------------------
Draft Guidance for the Preparation of March 3, 1997 Do. Do.
Premarket Notification 510(k)s for
Dental Alloys
----------------------------------------------------------------------------------------------------------------
Premarket Guidance; Reprocessing and June 1, 2001 Do. Do.
Reuse of Single-Use Devices; Draft
----------------------------------------------------------------------------------------------------------------
Guidance for Conducting Stability November 16, Do. Do.
Testing to Support an Expiration Date 1999
Labeling Claim for Medical Gloves;
Draft
----------------------------------------------------------------------------------------------------------------
Draft Version Cardiac Ablation March 1, 1995 Do. Do.
Preliminary Guidance (Data To Be
Submitted to the FDA in Support
Investigation Device Exemption
Application)
----------------------------------------------------------------------------------------------------------------
Draft Version Electrode Recording March 1, 1995 Do. Do.
Catheter Preliminary Guidance (Data
To Be Submitted to the FDA in Support
of Premarket Notifications)
----------------------------------------------------------------------------------------------------------------
Draft Replacement Heart Valve Guidance October 14, Do. Do.
1994
----------------------------------------------------------------------------------------------------------------
Draft Guidance on Human Heart Valve June 21, 1991 Do. Do.
Allografts
----------------------------------------------------------------------------------------------------------------
Draft Intravascular Brachytherapy-- May 24, 1996 Do. Do.
Guidance for Data To Be Submitted to
FDA in Support of Investigational
Device Exemption (IDE) Applications
----------------------------------------------------------------------------------------------------------------
Draft Guidance for the Submission of May 1, 1995 Do. Do.
Research and Marketing Applications
for Interventional Cardiology
Devices: PTCA Catheters, Atherectomy
Catheters, Lasers, Intravascular
Stents
----------------------------------------------------------------------------------------------------------------
Draft Percutaneous Transluminal February 7, Do. Do.
Coronary Angioplasty Package Insert 1995
Template
----------------------------------------------------------------------------------------------------------------
Draft Guidance for Implantable June 19, 1996 Do. Do.
Cardioverter-Defibrillators
----------------------------------------------------------------------------------------------------------------
Draft Guidance for the Preparation of August 1, 1993 Do. Do.
Research and Marketing Applications
for Vascular Graft Prostheses
----------------------------------------------------------------------------------------------------------------
Electroencephalograph Devices Draft November 3, Do. Do.
Guidance for 510(k) Content 1997
----------------------------------------------------------------------------------------------------------------
Draft 510(k) Guideline for General May 10, 1995 Do. Do.
Surgical Electrosurgical Devices
----------------------------------------------------------------------------------------------------------------
Galvanic Skin Response Measurement August 23, 1994 Do. Do.
Devices; Draft Guidance for 510(k)
Content
----------------------------------------------------------------------------------------------------------------
Draft Version 1; Biofeedback Devices; August 1, 1994 Do. Do.
Draft Guidance for 510(k) Content
----------------------------------------------------------------------------------------------------------------
Draft Version Cranial Perforator July 13, 1994 Do. Do.
Guidance
----------------------------------------------------------------------------------------------------------------
Draft Version Neuro Endoscope Guidance July 7, 1994 Do. Do.
----------------------------------------------------------------------------------------------------------------
Draft Premarket Notification Review June 1, 1994 Do. Do.
Guidance for Evoked Response
Somatosensory Stimulators
----------------------------------------------------------------------------------------------------------------
Draft Guidance for Arthroscope and May 1, 1994 Do. Do.
Accessory 510(k)s
----------------------------------------------------------------------------------------------------------------
[[Page 892]]
Guidance Document for Industry and March 18, 1998 Do. Do.
CDRH Staff for the Preparation of
Investigational Device Exemptions and
Premarket Approval Applications for
Bone Growth Stimulator Devices; Draft
----------------------------------------------------------------------------------------------------------------
Draft Guidance for Preparation of July 16, 1997 Do. Do.
Premarket Notification (510(k))
Applications for Orthopedic Devices:
The Basic Elements
----------------------------------------------------------------------------------------------------------------
Calcium Phosphate (Ca-P) Coating Draft February 21, Do. Do.
Guidance for Preparation of FDA 1997
Submission for Orthopedic and Dental
Endosseous Implants
----------------------------------------------------------------------------------------------------------------
Draft Guidance Document for Femoral August 1, 1995 Do. Do.
Stem Prostheses
----------------------------------------------------------------------------------------------------------------
Draft Guidance Document for Testing May 1, 1995 Do. Do.
Acetabular Cup Prostheses
----------------------------------------------------------------------------------------------------------------
Draft Data Requirements for Ultrahigh March 23, 1995 Do. Do.
Molecular Weight Polyethylene
(Uhmupe) Used in Orthopedic Devices
----------------------------------------------------------------------------------------------------------------
Draft Guidance for the Preparation of April 1, 1993 Do. Do.
Premarket Notifications (510(k)s) for
Cemented, Semiconstrained Total Knee
Prostheses
----------------------------------------------------------------------------------------------------------------
Draft Guidance for the Preparation of April 4, 1995 Do. Do.
IDE Submission for Interactive Wound
and Burn Dressing
----------------------------------------------------------------------------------------------------------------
Draft Guidance for the Preparation of March 31, 1995 Do. Do.
a Premarket Notification for a Non-
Interactive Wound and Burn Dressing
----------------------------------------------------------------------------------------------------------------
Draft Version; Guidance on September 12, Do. Do.
Biocompatibility Requirements for 1994
Long Term Neurological Implants: Part
3--Implant Model
----------------------------------------------------------------------------------------------------------------
Protocol for Dermal Toxicity Testing January 1, 1985 Do. Do.
for Devices in Contact with Skin;
Draft
----------------------------------------------------------------------------------------------------------------
Guide for TENS 510(k) Content; Draft August 1, 1994 Do. Do.
----------------------------------------------------------------------------------------------------------------
Draft Version Guidance for Clinical August 20, 1992 Do. Do.
Data To Be Submitted for Premarket
Approval Application for Cranial
Electrotherapy Stimulators
----------------------------------------------------------------------------------------------------------------
Draft Guidance for Cortical Electrode August 10, 1999 Do. Do.
510(k) Content
----------------------------------------------------------------------------------------------------------------
Accountability Analysis for Clinical August 4, 1999 Do. Do.
Studies for Ophthalmic Devices; Draft
----------------------------------------------------------------------------------------------------------------
Refractive Implants: Guidance for August 1, 2000 Do. Do.
Investigational Device Exemptions
(IDE) and Premarket Approval (PMA)
Applications; Draft
----------------------------------------------------------------------------------------------------------------
Intraocular Lens Guidance Document; October 14, Do. Do.
Draft 1999
----------------------------------------------------------------------------------------------------------------
Draft Guidance for Hemodialyzer Reuse October 6, 1995 Do. Do.
Labeling
----------------------------------------------------------------------------------------------------------------
Draft Guidance for Industry: Electro- August 25, 1999 Do. Do.
Optical Sensors for the In Vivo
Detection of Cervical Cancer and its
Precursors; Submission Guidance for
an IDE/PMA
----------------------------------------------------------------------------------------------------------------
Devices Used for In Vitro September 10, Do. Do.
Fertilization and Related Assisted 1988
Reproduction Procedures; Draft
----------------------------------------------------------------------------------------------------------------
[[Page 893]]
Intrapartum Continuous Monitors for June 14, 1997 Do. Do.
Fetal Oxygen Saturation and Fetal pH;
Submission Guidance for a PMA; Draft
Document
----------------------------------------------------------------------------------------------------------------
Draft Guidance for the Content of May 25, 1995 Do. Do.
Premarket Notifications for Menstrual
Tampons
----------------------------------------------------------------------------------------------------------------
Information for a Latex Condom 510(k) April 13, 1994 Do. Do.
Submission for Obstetrics-Gynecology
Devices Branch; Draft
----------------------------------------------------------------------------------------------------------------
Premarket Testing Guidelines for November 20, Do. Do.
Falloscopes 1992
----------------------------------------------------------------------------------------------------------------
Draft Guidance for the Content of July 29, 1991 Do. Do.
Premarket Notifications for Loop and
Rollerball Electrodes for GYN
Electrosurgical Excisions
----------------------------------------------------------------------------------------------------------------
Draft Guidance for Review of Bone November 9, Do. Do.
Densitometer 510(k) Submissions 1992
----------------------------------------------------------------------------------------------------------------
Draft Guidance for Preclinical and November 29, Do. Do.
Clinical Investigations of Urethral 1995
Bulking Agents Used in the Treatment
of Urinary Incontinence
----------------------------------------------------------------------------------------------------------------
Draft Guidance for Clinical November 2, Do. Do.
Investigation of Urethral Stents 1995
----------------------------------------------------------------------------------------------------------------
Draft 510(k) Checklist for Endoscopic August 16, 1995 Do. Do.
Electrosurgical Unit (ESU) and
Accessories Used in Gastroenterology
and Urology
----------------------------------------------------------------------------------------------------------------
Draft 510(k) Checklist for Urological August 1, 1995 Do. Do.
Irrigation System and Tubing Set
----------------------------------------------------------------------------------------------------------------
Draft 510(k) Checklist for Endoscopic June 22, 1995 Do. Do.
Light Sources Used in
Gastroenterology and Urology
----------------------------------------------------------------------------------------------------------------
Draft 510(k) Checklist for Non- June 6, 1995 Do. Do.
Implanted Electrical Stimulators Used
for the Treatment of Urinary
Incontinence
----------------------------------------------------------------------------------------------------------------
Draft Guidance for Preparation of PMA May 1, 1995 Do. Do.
Applications for the Implanted
Mechanical/Hydraulic Urinary
Continence Device (Artificial Urinary
Sphincter)
----------------------------------------------------------------------------------------------------------------
Draft Guidance for the Content of March 17, 1995 Do. Do.
Premarket Notifications for
Endoscopes Used in Gastroenterology
and Urology
----------------------------------------------------------------------------------------------------------------
Draft 510(k) Checklist for Condom February 23, Do. Do.
Catheters 1995
----------------------------------------------------------------------------------------------------------------
Draft Guidance for Clinical November 11, Do. Do.
Investigations of Devices Used for 1994
the Treatment of Benign Prostatic
Hyperplasia (BPH)
----------------------------------------------------------------------------------------------------------------
Draft Guidance Outline; PTC for November 30, Do. Do.
Clinical Studies for Vasovasostomy 1993
Devices
----------------------------------------------------------------------------------------------------------------
Draft Guidance for Preparation of PMA March 16, 1993 Do. Do.
Applications for Penile Inflatable
Implants
----------------------------------------------------------------------------------------------------------------
Draft Guidance for Preparation of PMA March 16, 1993 Do. Do.
Applications for Testicular
Prostheses
----------------------------------------------------------------------------------------------------------------
Draft Guidance for the Content of January 24, Do. Do.
Premarket Notifications for 1992
Urological Balloon Dilatation
Catheters
----------------------------------------------------------------------------------------------------------------
Draft of Suggested Information for January 18, Do. Do.
Reporting Extracorporeal Shock Wave 1991
Lithotripsy Device Shock Wave
Measurements
----------------------------------------------------------------------------------------------------------------
[[Page 894]]
Draft Guidance to Firms on Biliary August 2, 1990 Do. Do.
Lithotripsy Studies
----------------------------------------------------------------------------------------------------------------
Statistical Aspects of Submissions to June 1, 1984 Do. Do.
FDA: A Medical Device Perspective
(also includes as appendix the
article ``Observed Uses and Abuses of
Statistical Procedures in Medical
Device Submissions'')
----------------------------------------------------------------------------------------------------------------
Guidance to Sponsors on the June 9, 1993 Do. Do.
Development of a Discretionary
Postmarket Surveillance Study for
Permanent Implantable Cardiac
Pacemaker Electrodes (Leads)
----------------------------------------------------------------------------------------------------------------
Amendment to Guidance on Discretionary March 30, 1994 Do. Do.
Postmarket Surveillance on Pacemaker
Leads; Final
----------------------------------------------------------------------------------------------------------------
Premarketing Approval Review Criteria September 10, Do. Do.
for Premarket Approval of Estrogen 1992
(ER) or Progesterone (PGR) Receptors
In Vitro Diagnostic Devices Using
Steroid Hormone Binding (SBA) With
Dextran-Coated Charcoal (DCC)
Separation, Histochemical Receptor
Bind; Draft
----------------------------------------------------------------------------------------------------------------
Premarket Approval Applications for In April 27, 2001 Do. Do.
Vitro diagnostic Devices Pertaining
to Hepatitis C Viruses (HCV): Assays
Intended for Diagnosis, Prognosis, or
Monitoring of HCV Infection,
Hepatitis C, Other HCV-Associated
Disease; Draft Guidance for Industry
and FDA
----------------------------------------------------------------------------------------------------------------
Premarket Approval (PMA) Manual January 1998 Do. Do.
----------------------------------------------------------------------------------------------------------------
SMDA Changes--PMA Manual Insert April 17, 1992 Do. Do.
----------------------------------------------------------------------------------------------------------------
Investigational Device Exemptions June 1, 1996 Do. Do.
(IDE) Manual (FDA 96-4159)
----------------------------------------------------------------------------------------------------------------
510(k) Manual--Premarket Notification: August 1, 1995 Do. Do.
510(k)--Regulatory Requirements for
Medical Devices
----------------------------------------------------------------------------------------------------------------
Guidance Document for the Preparation July 26, 1995 Do. Do.
of Premarket Notification [510(k)]
Applications for Beds
----------------------------------------------------------------------------------------------------------------
\1\See Internet address for Facts-on-Demand number.
Guidance Documents Issued by CFSAN
------------------------------------------------------------------------
Intended User
Date of or How to Obtain
Name of Document Issuance Regulatory a Copy of the
Activity Document
------------------------------------------------------------------------
Compliance Policy Guides August General http://
Manual 2000; publications www.cfsan.fda
updated in .gov/
April 2001 guidance.html
------------------------------------------------------------------------
Compliance Programs Guidance March 1995 Do. Do.
Manual
------------------------------------------------------------------------
FDA Recall Policy 2002 Do. Do.
------------------------------------------------------------------------
Guidance for FDA Staff; The 2003 Do. Do.
Leveraging Handbook; An
Agency Resource for
Effective Collaborations
------------------------------------------------------------------------
Guidance for Small 2002 Do. Do.
Businesses; Submission of
Comments for CFSAN
Rulemaking
------------------------------------------------------------------------
Investigations Operations May 1996 Do. Do.
Manual
------------------------------------------------------------------------
Regulatory Procedures Manual August 1997 Do. Do.
------------------------------------------------------------------------
[[Page 895]]
Draft Guidance: Channels of July 2003 Chemical and Do.
Trade Policy for pesticide
Commodities With Residues contaminants
of Pesticide Chemicals, For publications
Which Tolerances Have Been
Revoked, Suspended, or
Modified by the
Environmental Protection
Agency
------------------------------------------------------------------------
Channels of Trade Policy for June 2002 Do. Do.
Commodities With
Vinclozolin Residues
------------------------------------------------------------------------
FDA Recommendations for January Do. Do.
Sampling and Testing Yellow 2001
Corn and Dry-Milled Yellow
Corn Shipments for Cry9C
Protein Residues
------------------------------------------------------------------------
Channels of Trade Policy for December Do. Do.
Commodities With Methyl 2000
Parathion Residues
------------------------------------------------------------------------
Action Levels for Poisonous 2000 Do. Do.
or Deleterious Substances
in Human Food and Animal
Feed
------------------------------------------------------------------------
Pesticides Analytical Manual 1999 Do. Do.
------------------------------------------------------------------------
FDA Advisory for September Do. Do.
Deoxynivanol (DON) in 1993
Finished Wheat Products
Intended for Human
Consumption and in Grain
and Grain By-Products for
Animal Feed
------------------------------------------------------------------------
FDA's Cosmetic Labeling October Cosmetic Do.
Manual 1991 publications
------------------------------------------------------------------------
Draft Guidance: Labeling for December 2, Do. Do.
Topically Applied Cosmetic 2002
Products Containing Alpha
Hydroxy Acids as
Ingredients
------------------------------------------------------------------------
Interim Procedures for July 10, Dietary Do.
Qualified Health Claims in 2003 supplements
the Labeling of publications
Conventional Human Food and
Human Dietary Supplements
------------------------------------------------------------------------
Interim Evidence-Based July 10, Do. Do.
Ranking System for 2003
Scientific Data
------------------------------------------------------------------------
Structure/Function Claims: January 9, Do. Do.
Small Entity Compliance 2002
Guide
------------------------------------------------------------------------
Statement of Identity, January Do. Do.
Nutrition Labeling, and 1999
Ingredient Labeling of
Dietary Supplements Small
Entity Compliance Guide
------------------------------------------------------------------------
Significant Scientific December Do. Do.
Agreement in the Review of 1999
Health Claims for
Conventional Foods and
Dietary Supplements
------------------------------------------------------------------------
Notification of a Health July 1998 Do. Do.
Claim or Nutrient Content
Claim Based on an
Authoritative Statement of
a Scientific Body
------------------------------------------------------------------------
Iron-Containing Supplements October 17, Do. Do.
and Drugs: Label Warning 2003
Statements: Small Entity
Compliance Guide
------------------------------------------------------------------------
Providing Regulatory July 2001 Food and Do.
Submissions in Electronic color
Format; General additives
Considerations publications
------------------------------------------------------------------------
Providing Food and Color July 2001 Do. Do.
Additive Petitions in
Electronic Format
------------------------------------------------------------------------
Electronic Submission Forms July 2001 Do. Do.
------------------------------------------------------------------------
FDA's Policy for Foods 1995 Do. Do.
Developed by Biotechnology
------------------------------------------------------------------------
Partial List of Enzyme 2001 Do. Do.
Preparations That Are Used
in Foods
------------------------------------------------------------------------
Partial List of 2001 Do. Do.
Microorganisms and
Microbial-Derived
Ingredients That Are Used
in Food
------------------------------------------------------------------------
Use of Antibiotic Resistance September Do. Do.
Marker Genes in Transgenic 1998
Plants
------------------------------------------------------------------------
Enzyme Preparations: January Do. Do.
Chemistry Recommendations 1993
for Food Additive and GRAS
Affirmation Petitions
------------------------------------------------------------------------
[[Page 896]]
Guidance for Submitting 1996 Do. Do.
Requests Under 21 CFR
170.39; Threshold of
Regulation for Substances
Used in Food Contact
Articles
------------------------------------------------------------------------
PTC for the Use of Recycled December Do. Do.
Plastics in Food Packaging: 1992
Chemistry Considerations
------------------------------------------------------------------------
How to Submit a GRAS Notice April 17, Do. Do.
1997
------------------------------------------------------------------------
Recommendations for May 1993 Do. Do.
Submission of Chemical and
Technological Data for
Direct Food Additive and
GRAS Food Ingredient
Petitions
------------------------------------------------------------------------
Statement of Policy; Foods May 1992 Do. Do.
Derived from New Plant
Varieties; Notice
------------------------------------------------------------------------
Guidelines for the 1996 Do. Do.
Preparation of Petition
Submissions
------------------------------------------------------------------------
Guidelines for Approval of 1996 Do. Do.
Color Additives in Contact
Lenses Intended as Colors
------------------------------------------------------------------------
FDA Recommendations for January Do. Do.
Submission of Chemical and 1997
Technological Data on Color
Additives for Food, Drug,
or Cosmetic Use
------------------------------------------------------------------------
Estimating Exposure to September Do. Do.
Direct Food Additive and 1995
Chemical Contaminants in
the Diet
------------------------------------------------------------------------
Toxicological Principles for 1982 Do. Do.
the Safety Assessment of
Direct Food Additives and
Color Additives Used in
Food (also known as redbook
I)
------------------------------------------------------------------------
Toxicological Principles for April 2004 Do. Do.
the Safety of Food
Ingredients (redbook 2000)
------------------------------------------------------------------------
Draft Guidance; Preparing a September Do. Do.
Claim of Categorical 17, 2003
Exclusion or an
Environmental Assessment
for Submission to CFSAN
------------------------------------------------------------------------
Environmental Assessment March 1987 Do. Do.
Technical Handbook
------------------------------------------------------------------------
Toxicological Testing of 1983 Do. Do.
Food Additives
------------------------------------------------------------------------
Guidance on Consultation October Do. Do.
Procedures Foods Derived 1997
From New Plant Varieties
------------------------------------------------------------------------
Bovine Spongiform 1997 Do. Do.
Encephalopathy (BSE) in
Products for Human Use
------------------------------------------------------------------------
Food Additive Petition January Do. Do.
Expedited Review; Guidance 1999
for Industry and CFSAN
------------------------------------------------------------------------
Antimicrobial Food Additives July 1999 Do. Do.
Guidance
------------------------------------------------------------------------
Preparation of Premarket May 2002 Do. Do.
Notifications for Food
Contact Substances (Food
Contact Notifications
(FCN)): Administrative
Recommendations
------------------------------------------------------------------------
Preparation of Food Contact April 2002 Do. Do.
Notifications and Food
Additive Petitions for Food
Contact Substances:
Chemistry Recommendations
------------------------------------------------------------------------
Preparation of Premarket April 2002 Do. Do.
Notifications for Food
Contact Substances:
Toxicology Recommendations
------------------------------------------------------------------------
A Food Labeling Guide May 1997 Food labeling Do.
publications
------------------------------------------------------------------------
Food Labeling: Trans Fatty August 20, Do. Do.
Acids in Nutrition 2003
Labeling, Nutrient Content
Claims, and Health Claims;
Small Entity Compliance
Guide
------------------------------------------------------------------------
[[Page 897]]
Qualified Health Claims in December Do. Do.
the Labeling of 18, 2002
Conventional Foods and
Dietary Supplements
------------------------------------------------------------------------
Draft Guidance; Voluntary January Do. Do.
Labeling Indicating Whether 2001
Foods Have or Have Not Been
Developed Using
Bioengineering
------------------------------------------------------------------------
Small Business Food Labeling June 1996 Do. Do.
Exemption
------------------------------------------------------------------------
Food Labeling: Questions and August 1994 Do. Do.
Answers (volume I)
------------------------------------------------------------------------
Food Labeling: Questions and February Do. Do.
Answers (volume II) 1996
------------------------------------------------------------------------
Fair Packaging and Labeling June 1978 Do. Do.
Act Manual
------------------------------------------------------------------------
Implementation of Section 2002 Do. Do.
10809 of the Farm Security
and Investment Act of 2002,
Public Law No. 107-171,
Sec. 10809 (2002),
Regarding the Petition
Process to Request Approval
of Labeling for Foods That
Have Been Treated by
Irradiation
------------------------------------------------------------------------
FDA Nutrition Labeling March 1998 Do. Do.
Manual--A Guide for
Developing and Using
Databases
------------------------------------------------------------------------
Guidelines for Determining October 1, Do. Do.
Metric Equivalents of 1993
Household Measures
------------------------------------------------------------------------
Food Labeling--Safe Handling July 2001 Do. Do.
Statements, Labeling of
Shell Eggs; Refrigeration
of Shell Eggs Held for
Retail Distribution; Small
Entity Compliance Guide
------------------------------------------------------------------------
Exemptions From the Warning October 7, Do. Do.
Label Requirement for 2002
Juice--Recommendations for
Effectively Achieving a 5-
Log Pathogen Reduction
------------------------------------------------------------------------
Food Labeling--Serving Sizes July 2001 Do. Do.
Reference Amount for Baking
Powder, Baking Soda,
Pectin; Small Entity
Compliance Guide
------------------------------------------------------------------------
Bacteriological Analytical 1992 Food Do.
Manual (7th ed.) processing
publicatons
------------------------------------------------------------------------
Bacteriological Analytical 2001 Do. Do.
Manual Online
------------------------------------------------------------------------
Questions and Answers August 6, Food and Do.
Regarding Registration of 2004 cosmetic
Food Facilities (4th ed.) security
publications
------------------------------------------------------------------------
Cosmetics Processors and December Do. Do.
Transporters: Cosmetics 17, 2003
Security Preventive
Measures Guidance
------------------------------------------------------------------------
Retail Food Stores and Food December Do. Do.
Service Establishments: 17, 2003
Food Security Preventive
Measures Guidance
------------------------------------------------------------------------
What You Need to Know About November Do. Do.
Registration of Food 25, 2003
Facilities
------------------------------------------------------------------------
What You Need to Know About November Do. Do.
Prior Notice of Imported 25, 2003
Food Shipments
------------------------------------------------------------------------
Necessity of the Use of Food July 17, Do. Do.
Product Categories in 2003
Registration of Food
Facilities
------------------------------------------------------------------------
Dairy Farms, Bulk Milk July 11, Do. Do.
Transporters, Bulk Milk 2003
Transfer Stations, and
Fluid Milk Processors: Food
Security Preventive
Measures Guidance
------------------------------------------------------------------------
Food Producers, Processors, March 21, Do. Do.
and Transporters: Food 2003
Security Preventive
Measures Guidance
------------------------------------------------------------------------
Importers and Filers: Food March 21, Do. Do.
Security Preventive 2003
Measures Guidance
------------------------------------------------------------------------
[[Page 898]]
Compliance Policy Guide; 2003 Do. Do.
Guidance for FDA Staff on
Registration of Food
Facilities
------------------------------------------------------------------------
Compliance Policy Guide; 2003 Do. Do.
Guidance for FDA Staff on
Prior Notice of Imported
Foods
------------------------------------------------------------------------
Prior Notice of Imported May 2004 Imports and Do.
Food Questions and Answers exports
(2nd ed.) publications
------------------------------------------------------------------------
Prior Notice of Imported August 2004 Do. Do.
Food: Harmonized Tariff
Schedule Codes Flagged With
Prior Notice Indicators
------------------------------------------------------------------------
Guidance for Industry and May 23, Do. Do.
FDA; Establishing and 2003
Maintaining a List of U.S.
Dairy Product Manufacturers/
Processors With Interest in
Exporting to Chile
------------------------------------------------------------------------
FDA Food Importer's Guide 1985 Do. Do.
for Low-Acid Canned and
Acidified Foods
------------------------------------------------------------------------
Guidance for Industry; FDA 2002 Do. Do.
Export Certificates
------------------------------------------------------------------------
Draft Guidance; Regulatory November 5, Do. Do.
Procedures Manual, chapter 2002
9, subchapter: Guidance
Concerning Recommending
Customs' Seizure and
Destruction of Imported
Human and Animal Food That
Has Not Been Reconditioned
------------------------------------------------------------------------
Guidelines Concerning 1985 Infant Do.
Notification and Testing of formula
Infant Formula publications
------------------------------------------------------------------------
Guidelines for Evaluation of 1988 Do. Do.
the Safety and Suitability
of New Infant Formulas for
Feeding Preterm Infants
------------------------------------------------------------------------
Clinical Testing of Infant 1988 Do. Do.
Formulas With Respect to
Nutritional Suitability for
Term Infants
------------------------------------------------------------------------
Guidelines for Evaluation of 1990 Do. Do.
the Safety and Suitability
of Infant Formulas for
Feeding Infants With
Allergic Diseases
------------------------------------------------------------------------
Guidelines for the Clinical 1987 Do. Do.
Evaluation of New Products
Used in the Dietary
Management of Infants,
Children, and Pregnant
Women With Metabolic
Disorders
------------------------------------------------------------------------
The Juice HACCP Regulation: September Juice Do.
Questions and Answers 4, 2003 publications
------------------------------------------------------------------------
Standardized Training June 2003 Do. Do.
Curriculum for Application
of HACCP Principles to
Juice Processing
------------------------------------------------------------------------
Bulk Transport of Juice April 24, Do. Do.
Concentrates and Certain 2002
Shelf Stable Juices
------------------------------------------------------------------------
Juice HACCP Small Entity April 4, Do. Do.
Compliance Guide 2003
------------------------------------------------------------------------
Draft Guidance; Juice HACCP March 3, Do. Do.
Hazards and Control 2004
Guidance (1st ed.)
------------------------------------------------------------------------
Apple Juice, Apple Juice October Do. Do.
Concentrates, and Apple 2001
Juice Products--
Adulteration With Patulin
------------------------------------------------------------------------
The Juice HACCP Regulation: August 31, Do. Do.
Questions and Answers 2001
------------------------------------------------------------------------
FDA Food Importer's Guide 1985 Low-acid and Do.
for Low-Acid Canned and acidified
Acidified Foods foods
publications
------------------------------------------------------------------------
Grade ``A'' Pasteurized Milk May 15, Milk Do.
Ordinance (2001 revision) 2002 sanitation
publications
------------------------------------------------------------------------
Importation of PMO Defined April 11, Do. Do.
Dairy Products (M-I-00-4) 2000
------------------------------------------------------------------------
Evaluation of Milk 1995 Do. Do.
Laboratories
------------------------------------------------------------------------
[[Page 899]]
Methods of Making Sanitation 1999 Do. Do.
Ratings of Milk Supplies
------------------------------------------------------------------------
Procedures Governing the 1999 Do. Do.
Cooperative State-Public
Health Service/FDA Program
for Certification of
Interstate Milk Shippers
------------------------------------------------------------------------
Frozen Dessert Processing 1989 Do. Do.
Guidelines
------------------------------------------------------------------------
Dry Milk Ordinance 1995 Do. Do.
------------------------------------------------------------------------
Pasteurized Milk Ordinance 1999 Do. Do.
------------------------------------------------------------------------
Fumonisin Levels in Human November 9, Natural Do.
Foods and Animal Feeds 2001 toxins
publications
------------------------------------------------------------------------
List of Products for Each October 8, Nutrition and Do.
Product Category 1992 food science
publications
------------------------------------------------------------------------
Label Declaration of June 10, Do. Do.
Allergenic Substances in 1996
Foods; Notice to
Manufacturers
------------------------------------------------------------------------
Guidance on Labeling of February Do. Do.
Foods That Need 24, 1997
Refrigeration by Consumers
------------------------------------------------------------------------
Interim Guidance on the February Do. Do.
Voluntary Labeling of Milk 10, 1994
and Milk Products That Have
Not Been Treated With
Recombinant Bovine
Somatropin
------------------------------------------------------------------------
Guide to Minimize Microbial October 26, Produce Do.
Food Safety Hazards for 1998 publications
Fresh Fruits and Vegetables
------------------------------------------------------------------------
Reducing Microbial Food October Do. Do.
Safety Hazards for Sprouted 1999
Seeds
------------------------------------------------------------------------
Sampling and Microbial October Do. Do.
Testing of Spent Irrigation 1999
Water During Sprout
Production
------------------------------------------------------------------------
Retail Food Stores and Food December Retail food Do.
Service Establishments: 17, 2003 protection
Food Security Preventive publications
Measures Guidance
------------------------------------------------------------------------
Foods--Adulteration February Sanitation Do.
Involving Hard or Sharp 1999 publications
Foreign Objects
------------------------------------------------------------------------
Defect Action Levels (DALs) May 1998 Do. Do.
------------------------------------------------------------------------
Action Levels for Poisonous 2000 Do. Do.
or Deleterious Substances
in Human Food and Feed
------------------------------------------------------------------------
Refusal of Inspection or July 2001 Seafood Do.
Access to HACCP Records publications
Pertaining to the Safe and
Sanitary Processing of Fish
and Fishery Products
------------------------------------------------------------------------
Seafood HACCP Transition December Do. Do.
Policy 1999
------------------------------------------------------------------------
Seafood List 1993 Do. Do.
------------------------------------------------------------------------
Fish and Fisheries Products 2001 Do. Do.
Hazards and Control Guide
(3rd ed.)
------------------------------------------------------------------------
HACCP Regulation for Fish 1998 Do. Do.
and Fishery Products:
Questions and Answers
------------------------------------------------------------------------
Implementation of Section December Do. Do.
403(t) of the Federal Food, 2002
Drug, and Cosmetic Act (21
U.S.C. 343(t)) Regarding
the Use of the Term
``Catfish''
------------------------------------------------------------------------
Letter to Various Seafood February Do. Do.
Trade Associations 28, 2003
Regarding the Labeling of
Catfish
¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤
WITHDRAWN GUIDANCES
------------------------------------------------------------------------
[[Page 900]]
Guidance for Industry: June 2000 N/A N/A
Fumonisin Levels in Human
Foods and Animal Feeds,
Draft (replaced by Guidance
for Industry: Fumonisin
Levels in Human Foods and
Animal Feeds; Final
(November 2001)
------------------------------------------------------------------------
Guidance for Industry December Do. Do.
Qualified Health Claims in 2002
the Labeling of
Conventional Foods and
Dietary Supplements
(replaced by Interim
Procedures for Qualified
Health Claims in the
Labeling of Conventional
Human Food and Human
Dietary Supplements and
Interim Evidence-Based
Ranking System for
Scientific Data (July
2003))
------------------------------------------------------------------------
Guidance for Industry June 2000 Do. Do.
Preparation of Premarket
Notifications for Food
Contact Substances:
Administrative; Draft
(replaced by Guidance for
Industry Preparation of
Premarket Notifications for
Food Contact Substances:
Administrative; Final (May
2002))
------------------------------------------------------------------------
Guidance for Industry May 2000 Do. Do.
Preparation of Premarket
Notifications for Food
Contact Substances:
Chemistry Recommendations,
Draft (replaced by Guidance
for Industry Preparation of
Food Contact Notifications
for Food Contact
Substances: Chemistry
Recommendations; Final
(April 2002))
------------------------------------------------------------------------
Recommendations for June 1995 Do. Do.
Chemistry Data for Indirect
Food Additive Petitions
(replaced by Guidance for
Industry Preparation of
Food Contact Notifications
for Food Contact
Substances: Chemistry
Recommendations; Final
(April 2002))
------------------------------------------------------------------------
Guidance for Industry September Do. Do.
Preparation of Premarket 1999
Notifications for Food
Contact Substances:
Toxicology Recommendations
(replaced by Guidance for
Industry Preparation of
Food Contact Notifications
for Food Contact
Substances: Toxicology
Recommendations; Final
(April 2002))
------------------------------------------------------------------------
Iron-Containing Supplements November Do. Do.
and Drugs: Label Warning 1997
and Unit Dose Packaging
Small Entity Compliance
Guide (replaced by Guidance
for Industry; Iron-
Containing Supplements and
Drugs: Label Warning
Statements; Small Entity
Compliance Guide (October
2003))
------------------------------------------------------------------------
Guidance for Industry July 2001 Do. Do.
Channels of Trade Policy
for Commodities With
Vinclozolin Residues; Draft
(replaced by Guidance for
Industry Channels of Trade
Policy for Commodities With
Vinclozolin Residues; Final
(June 2002))
------------------------------------------------------------------------
Guidance for Industry November Do. Do.
Refusal of Inspection or 2000
Access to HACCP Records
Pertaining to the Safe and
Sanitary Processing of Fish
and Fishery Products; Draft
(replaced by Guidance for
Industry Refusal of
Inspection or Access to
HACCP Records Pertaining to
the Safe and Sanitary
Processing of Fish and
Fishery Products; Final
(July 2001))
------------------------------------------------------------------------
Guidance Document for 1993 Do. Do.
Arsenic
------------------------------------------------------------------------
Guidance Document for 1993 Do. Do.
Cadmium
------------------------------------------------------------------------
Guidance Document for 1993 Do. Do.
Chromium
------------------------------------------------------------------------
Guidance Document for Lead 1993 Do. Do.
------------------------------------------------------------------------
Guidance Document for Nickel 1993 Do. Do.
------------------------------------------------------------------------
[[Page 901]]
Guidance Documents Issued by CVM
------------------------------------------------------------------------
Intended User
Date of or How to Obtain
Name of Document Issuance Regulatory a Copy of the
Activity Document
------------------------------------------------------------------------
159 Studies to November FDA personnel Internet via
Evaluate the Safety of 12, 2003 and http://
Residues of Veterinary regulated www.fda.gov/
Drugs in Human Food: industry cvm/guidance/
General Approach to published.htm
Establish a Microbiological , or
ADI (VICH GL36) Communication
s Staff (HFV-
12), FDA/CVM,
7519 Standish
Pl.,
Rockville,
MD, 301-827-
3800, FAX:
301-827-4065
------------------------------------------------------------------------
158 Use of Material September Regulated Do.
From Deer and Elk in Animal 15, 2003 industry
Feed; Final
------------------------------------------------------------------------
156 Comparability February Do. Do.
Protocols; Chemistry, 2003
Manufacturing, and Controls
Information; Draft
------------------------------------------------------------------------
153 Drugs, September Do. Do.
Biologics, and Medical 2002
Devices Derived From
Bioengineered Plants for
Use in Humans and Animals;
Draft
------------------------------------------------------------------------
152 Evaluating the October 23, Do. Do.
Safety of Antimicrobial New 2003
Animal Drugs With Regard to
Their Microbiological
Effects on Bacteria of
Human Health Concern
------------------------------------------------------------------------
151 FDA Export July 2004 Do. Do.
Certificates
------------------------------------------------------------------------
150 Status of Clove June 11, Do. Do.
Oil and Eugenol for 2002
Anesthesia of Fish
------------------------------------------------------------------------
149 Studies to May 18, Do. Do.
Evaluate the Safety of 2004
Residues of Veterinary
Drugs in Human Food:
General Approach to Testing
(VICH GL33)
------------------------------------------------------------------------
148 Studies to March 19, Do. Do.
Evaluate the Safety of 2004
Residues of Veterinary
Drugs in Human Food:
Developmental Toxicity
Testing (VICH GL32); Final
Guidance
------------------------------------------------------------------------
147 Studies to November Do. Do.
Evaluate the Safety of 12, 2003
Residues of Veterinary
Drugs in Human Food; Repeat
Dose (90-day) Toxicity
Testing (VICH GL31)
------------------------------------------------------------------------
145 Bioanalytical May 2001 Do. Do.
Method Validation
------------------------------------------------------------------------
144 Pre-Approval April 27, Do. Do.
Information for 2004
Registration of New
Veterinary Medicinal
Products for Food-producing
Animals with Respect to
Antimicrobial Resistance
(VICH GL27); Final Guidance
------------------------------------------------------------------------
143 February 1, Do. Do.
Pharmacovigilance of 2002
Veterinary Medicinal
Products: Controlled List
of Terms (VICH GL30); Draft
Guidance
------------------------------------------------------------------------
142 December Do. Do.
Pharmacovigilance of 12, 2001
Veterinary Medicinal
Products: Management of
Periodic Summary Update
Reports (PSUs) (VICH GL29);
Draft Guidance
------------------------------------------------------------------------
141 Studies to May 24, Do. Do.
Evaluate the Safety of 2004
Residues of Veterinary
Drugs in Human Food:
Carcinogenicity Testing
(VICH GL28); Final Guidance
------------------------------------------------------------------------
132 The November 6, Do. Do.
Administrative New Animal 2002
Drug Application Process;
Draft
------------------------------------------------------------------------
126 BACPAC I: February Do. Do.
Intermediates in Drug 2001
Substance Synthesis; Bulk
Actives Postapproval
Changes: Chemistry,
Manufacturing, and Controls
Documentation
------------------------------------------------------------------------
124 Voluntary January Do. Do.
Labeling Indicating Whether 2001
Foods Have or Have Not Been
Developed Using
Bioengineering; Draft
------------------------------------------------------------------------
122 Manufacture and November 9, Do. Do.
Labeling of Raw Meat Foods 2004
for Companion and Captive
Noncompanion Carnivores and
Omnivores
------------------------------------------------------------------------
[[Page 902]]
121 Expedited March 6, Do. Do.
Review for New Animal Drug 2001
Applications for Human
Pathogen Reduction Claims
------------------------------------------------------------------------
120 Veterinary March 1, Do. Do.
Feed Directive Regulation 2001
------------------------------------------------------------------------
119 How CVM August 29, Do. Do.
Intends to Handle Deficient 2002
Submissions Filed During
the Investigation of a New
Animal Drug; Final Guidance
------------------------------------------------------------------------
118 Mass May 1, 2003 Do. Do.
Spectrometry for
Confirmation of the
Identity of Animal Drug
Residues; Final Guidance
------------------------------------------------------------------------
117 December Do. Do.
Pharmacovigilance of 12, 2000
Veterinary Medical
Products: Management of
Adverse Event Reports
(AERs) (VICH GL24); Draft
Guidance
------------------------------------------------------------------------
116 Studies to January 3, Do. Do.
Evaluate the Safety of 2002
Residues of Veterinary
Drugs in Human Food:
Genotoxicity Testing (VICH
GL23); Final Guidance
------------------------------------------------------------------------
115 Safety Studies January 3, Do. Do.
for Veterinary Drug 2002
Residues in Human Food;
Reproduction Toxicity
Testing (VICH GL22); Final
Guidance
------------------------------------------------------------------------
114 Effectiveness June 19, Do. Do.
of Anthelmintics: Specific 2002
Recommendations for Poultry-
Gallus Gallus (VICH GL21);
Final Guidance
------------------------------------------------------------------------
113 Effectiveness June 19, Do. Do.
of Anthelmintics: Specific 2002
Recommendations for Feline
(VICH GL20); Final Guidance
------------------------------------------------------------------------
112 Fumonisin November 9, Do. Do.
Levels in Human Foods and 2001
Animal Feeds; Final
Guidance
------------------------------------------------------------------------
111 Effectiveness June 27, Do. Do.
of Anthelmintics: Specific 2002
Recommendations for Canine
(VICH GL19); Final Guidance
------------------------------------------------------------------------
110 Effectiveness June 27, Do. Do.
of Anthelmintics: Specific 2002
Recommendations for Porcine
(VICH GL16); Final Guidance
------------------------------------------------------------------------
109 Effectiveness June 27, Do. Do.
of Anthelmintics: Specific 2002
Recommendations for Equine
(VICH GL15); Final Guidance
------------------------------------------------------------------------
108 How to Submit May 21, Do. Do.
Information in Electronic 2004
Format by E-mail
------------------------------------------------------------------------
107 How to Submit a May 21, Do. Do.
Protocol in Electronic 2004
Format by E-mail
------------------------------------------------------------------------
106 The Use of August 31, Do. Do.
Published Literature in 2000
Support of New Animal Drug
Approval
------------------------------------------------------------------------
105 Computerized September Do. Do.
Systems Used in Clinical 2004
Trials
------------------------------------------------------------------------
104 Content and July 10, Do. Do.
Format of Effectiveness and 2001
Target Animal Safety
Technical Sections and
Final Study Reports for
Submission to the Division
of Therapeutic Drugs for
Nonfood Animals
------------------------------------------------------------------------
103 Possible Dioxin/ August 1999 Do. Do.
PCB Contamination of Drug
and Biological Products
------------------------------------------------------------------------
102 Manufacture and August 27, Do. Do.
Distribution of Unapproved 1999
Piperazine Products;
Revised
------------------------------------------------------------------------
100 Impurities: May 15, Do. Do.
Residual Solvents in New 2001
Veterinary Medicinal
Products, Active Substances
and Excipients (VICH GL18);
Final Guidance
------------------------------------------------------------------------
99 Stability March 26, Do. Do.
Testing of New 2001
Biotechnological/Biological
Veterinary Medicinal
Products (VICH GL17); Final
Guidance
------------------------------------------------------------------------
[[Page 903]]
98 Dioxin in April 14, Do. Do.
Anticaking Agents Used in 2000
Animal Feed and Feed
Ingredients; Revised
------------------------------------------------------------------------
97 Effectiveness of March 26, Do. Do.
Anthelmintics: Specific 2001
Recommendations for Caprine
(VICH GL14); Final Guidance
------------------------------------------------------------------------
96 Effectiveness of March 26, Do. Do.
Anthelmintics: Specific 2001
Recommendations for Ovine
(VICH GL13); Final Guidance
------------------------------------------------------------------------
95 Efficacy of March 26, Do. Do.
Anthelmintics: Specific 2001
Recommendations for
Bovines; (VICH GL12); Final
Guidance
------------------------------------------------------------------------
93 Impurities in May 1, 2000 Do. Do.
New Veterinary Medical
Products (VICH GL11)
------------------------------------------------------------------------
92 Impurities in May 1, 2000 Do. Do.
New Veterinary Drug
Substances (VICH GL10)
------------------------------------------------------------------------
91 Stability March 2000 Do. Do.
Testing for Medicated
Premixes (VICH GL8); Final
Guidance
------------------------------------------------------------------------
90 Effectiveness of October 11, Do. Do.
Anthelmintics: General 2001
Recommendations (VICH GL7);
Final Guidance (replaces
March 26, 2001)
------------------------------------------------------------------------
89 Environmental March 7, Do. Do.
Impact Assessments (EIAs) 2001
for Veterinary Medicinal
Products (VMPs)--Phase I
(VICH GL6); Final Guidance
------------------------------------------------------------------------
88 How to Submit a May 21, Do. Do.
Request for a Meeting or 2004
Teleconference in
Electronic Format by E-mail
------------------------------------------------------------------------
87 How to Submit a May 21, Do. Do.
Notice of Intent to 2004
Slaughter for Human Food
Purposes in Electronic
Format by E-mail
------------------------------------------------------------------------
86 How to Submit a May 21, Do. Do.
Notice of Final Disposition 2004
of Investigational Animals
Not Intended for Immediate
Slaughter in Electronic
Format by E-mail
------------------------------------------------------------------------
85 Good Clinical May 9, 2001 Do. Do.
Practice (VICH GL9); Final
Guidance
------------------------------------------------------------------------
84 Product Name January Do. Do.
Placement, Size and 1999
Prominence in Advertising
and Promotional Labeling;
Draft Guidance
------------------------------------------------------------------------
83 Chemistry, June 1999 Do. Do.
Manufacturing, and Controls
Changes to an Approved NADA
or ANADA; Draft Guidance
------------------------------------------------------------------------
82 Development of October 28, Do. Do.
Supplemental Applications 2002
for Approved New Animal
Drugs; Final Guidance
------------------------------------------------------------------------
80 Studies to November Do. Do.
Evaluate the Utility of 21, 2002
Anti-Salmonella Chemical
Food Additives in Feeds
------------------------------------------------------------------------
79 Dispute May 16, Do. Do.
Resolution Procedures for 2003
Science-Based Decisions on
Products Regulated by CVM;
Draft Guidance
------------------------------------------------------------------------
78 Consideration of December Do. Do.
the Human Health Impact of 13, 1999
the Microbial Effects of
Antimicrobial New Animal
Drugs Intended for Use in
Food-Producing Animals
------------------------------------------------------------------------
76 Questions and July 1998 Do. Do.
Answers: BSE Feed
Regulation
------------------------------------------------------------------------
75 Stability September Do. Do.
Testing: Photostability 1999
Testing of New Veterinary
Drug Substances and
Medicinal Products; Final
Guidance
------------------------------------------------------------------------
74 Stability September Do. Do.
Testing of New Veterinary 1999
Dosage Forms (VICH GL4);
Final Guidance
------------------------------------------------------------------------
73 Stability September Do. Do.
Testing of New Veterinary 1999
Drug Substances and
Medicinal Products (VICH
GL3); Final Guidance
------------------------------------------------------------------------
[[Page 904]]
72 GMPs for May 1998 Do. Do.
Medicated Feed
Manufacturers Not Required
to Register and Be Licensed
With FDA
------------------------------------------------------------------------
70 Para February Do. Do.
Alimentadores de Animales 1998
Rumiantes Sin Operaciones
de Mezclado de Alimentos en
la Granja
------------------------------------------------------------------------
70 Small Entities February Do. Do.
Compliance Guide for 1998
Feeders of Ruminant Animals
Without On-Farm Feed Mixing
Operations
------------------------------------------------------------------------
69 Para February Do. Do.
Alimentadores de Animales 1998
Rumiantes Con Operaciones
de Mezclado de Alimentos en
la Granja
------------------------------------------------------------------------
69 Small Entities February Do. Do.
Compliance Guide for 1998
Feeders of Ruminant Animals
With On-Farm Feed Mixing
Operations
------------------------------------------------------------------------
68 Para Mezcladores February Do. Do.
de Prote[Iacute]nas, 1999
Fabricantes de Alimentos
para Animales y
Distribuidores
------------------------------------------------------------------------
68 Small Entities February Do. Do.
Compliance Guide for 1998
Protein Blenders, Feed
Manufacturers, and
Distributors
------------------------------------------------------------------------
67 Para Extractores February Do. Do.
de Grasa por Fusion 1998
------------------------------------------------------------------------
67 Small Entities February Do. Do.
Compliance Guide for 1998
Renderers
------------------------------------------------------------------------
65 Industry- November Do. Do.
Supported Scientific and 1997
Educational Activities
------------------------------------------------------------------------
64 Validation of July 1999 Do. Do.
Analytical Procedures:
Methodology; Final Guidance
------------------------------------------------------------------------
63 Validation of July 1999 Do. Do.
Analytical Procedures:
Definition and Terminology
------------------------------------------------------------------------
62 Consumer- August 1999 Do. Do.
Directed Broadcast
Advertisements; Final
Guidance
------------------------------------------------------------------------
61 FDA Approval of April 1999 Do. Do.
New Animal Drugs for Minor
Uses and for Minor Species
------------------------------------------------------------------------
59 How to Submit a May 21, Do. Do.
Notice of Claimed 2004
Investigational Exemption
in Electronic Format by E-
mail
------------------------------------------------------------------------
57 Guidance for 1995 Do. Do.
Industry for the
Preparation and Submission
of Veterinary Master Files
------------------------------------------------------------------------
56 Protocol July 10, Do. Do.
Development Guideline for 2001
Clinical Effectiveness and
Target Animal Safety Trials
------------------------------------------------------------------------
55 Supportive Data June 1994 Do. Do.
for Cat Food Labels Bearing
``Reduces Urinary pH''
Claims: Guideline in
Protocol Development
------------------------------------------------------------------------
54 Draft Guideline June 22, Do. Do.
for Utility Studies for 1994
Anti-Salmonella Chemical
Food Additives in Animal
Feeds (see final guidance
80)
------------------------------------------------------------------------
53 Guideline for May 1994 Do. Do.
the Evaluation of the
Utility of Food Additives
in Diets Fed to Aquatic
Animals
------------------------------------------------------------------------
52 Assessment of February Do. Do.
the Effects of 18, 2004
Antimicrobial Drug Residues
From Food of Animal Origin
on the Human Intestinal
Flora
------------------------------------------------------------------------
50 Draft Guideline February 1, Do. Do.
for Target Animal and Human 1993
Food Safety, Drug Efficacy,
Environmental and
Manufacturing Studies for
Teat Antiseptic Products
------------------------------------------------------------------------
49 Guidance April 4, Do. Do.
Document for Target Animal 1996
Safety and Drug
Effectiveness Studies for
Antimicrobial Bovine
Mastitis Products
(Lactating and Nonlactating
Cow Products)
------------------------------------------------------------------------
[[Page 905]]
48 Guidance for November Do. Do.
Industry for the Submission 1994
Documentation for
Sterilization Process
Validation in Applications
for Human and Veterinary
Drug Products
------------------------------------------------------------------------
45 Guideline for August 1993 Do. Do.
Uniform Labeling of Drugs
for Dairy and Beef Cattle
------------------------------------------------------------------------
43 Guidance on October Do. Do.
Generic Animal Drug 1995
Products Containing
Fermentation-Derived Drug
Substances
------------------------------------------------------------------------
42 Animal Drug 1994 Do. Do.
Manufacturing Guidelines
------------------------------------------------------------------------
41 Draft Guideline June 1992 Do. Do.
for Formatting, Assembling,
and Submitting New Animal
Drug Applications
------------------------------------------------------------------------
40 Draft Guideline April 1992 Do. Do.
for the Evaluation of the
Efficacy of Anticoccidial
Drugs and Anticoccidial
Drug Combinations in
Poultry
------------------------------------------------------------------------
38 Guideline for August 21, Do. Do.
Effectiveness Evaluation of 1984
Topical/OTIC Animal Drugs
------------------------------------------------------------------------
37 Guidelines for March 1984 Do. Do.
Evaluation of Effectiveness
of New Animal Drugs for Use
in Poultry Feeds for
Pigmentation
------------------------------------------------------------------------
36 Guideline for July 18, Do. Do.
Efficacy Evaluation of 1985
Canine/Feline Anthelmintics
------------------------------------------------------------------------
35 Bioequivalence Revised Do. Do.
Guideline October 9,
2002
------------------------------------------------------------------------
33 Target Animal June 1989 Do. Do.
Safety Guidelines for New
Animal Drugs
------------------------------------------------------------------------
31 Guidelines for July 1981 Do. Do.
the Evaluation of Bovine
Anthelmintics
------------------------------------------------------------------------
29 Guidelines for September Do. Do.
the Effectiveness 30, 1980
Evaluation of Swine
Anthelmintics
------------------------------------------------------------------------
28 Animal Drug December 3, Do. Do.
Applications Expedited 1997
Review Guideline (see
Policy and Procedures Guide
1240.3135)
------------------------------------------------------------------------
27 New Animal Drug July 1989 Do. Do.
Determination (see Policy
and Procedures Guide
1240.3500)
------------------------------------------------------------------------
24 Guideline for October Do. Do.
Drug Combinations for Use 1983
in Animals
------------------------------------------------------------------------
23 Medicated Free- July 1, Do. Do.
Choice Feeds-Manufacturing 1985
Controls
------------------------------------------------------------------------
22 Labeling of ........... Do. Do.
Arecoline Base Drugs
Intended for Animal Use
------------------------------------------------------------------------
21 Nutritional March 1993 Do. Do.
Ingredients in Animal Drugs
and Feeds (see Policy and
Procedures Guide 1240.3420)
------------------------------------------------------------------------
16 Freedom of May 10, Do. Do.
Information Summary 1985
Guidelines
------------------------------------------------------------------------
13 Guidelines for January Do. Do.
Evaluation and 1985
Effectiveness of New Animal
Drugs for Use in Free-
Choice Feeds (revision of
The Cattle Medicated Block
Guideline)
------------------------------------------------------------------------
10 Amendment of October Do. Do.
Section II(G)(1)(b)(4) of 1975
the Preclearance Guidelines
------------------------------------------------------------------------
9 Preclearance Withdrawn Do. Do.
Guidelines for Production pending
Drugs revisions
------------------------------------------------------------------------
6 Guideline for October 20, Do. Do.
Submitting NADAs for 1971;
Generic Drugs Reviewed by revised
NAS/NRC March 19,
1976
------------------------------------------------------------------------
5 Drug Stability December 1, Do. Do.
Guidelines 1990
------------------------------------------------------------------------
[[Page 906]]
3 General July 1994 Do. Do.
Principles for Evaluating
the Safety of Compounds
Used in Food-Producing
Animals (revised) (see
guidance 118 for
update to Section V.B.1)
¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤
WITHDRAWN DOCUMENTS
------------------------------------------------------------------------
58 Guidance for May 1997 N/A N/A
Industry; Good Target
Animal Study Practices:
Clinical Investigators and
Monitors
------------------------------------------------------------------------
155 Guidance for March 1997/ Do. Do.
Industry; 21 CFR Part 11; February
Electronic Records; 2003
Electronic Signatures,
Electronic Copies of
Electronic Records
------------------------------------------------------------------------
154 Draft Guidance March 1997/ Do. Do.
for Industry on Part 11; February
Electronic Records, 2003
Electronic Signatures--
Scope and Application
------------------------------------------------------------------------
77 Interpretation September Do. Do.
of On-Farm Feed 1998/June
Manufacturing and Mixing 2003
Operations
------------------------------------------------------------------------
66 Professional August 1998/ Do. Do.
Flexible Labeling of January
Antimicrobial Drugs 2002
20 Antibacterial December Do. Do.
Drugs in Animal Feeds: 2004
Antibacterial Effectiveness
Criteria
------------------------------------------------------------------------
19 Antibacterial December Do. Do.
Drugs in Animal Feeds: 2004
Animal Health Safety
Criteria
------------------------------------------------------------------------
18 Antibacterial December Do. Do.
Drugs in Animal Feeds: 2004
Human Health Safety
Criteria
------------------------------------------------------------------------
15 Guideline for February Do. Do.
Reporting the Details of 1977/
Clinical Trials Using an December
Investigational New Animal 2004
Drug in Non-Food Producing
Animals
------------------------------------------------------------------------
14 Guideline for December Do. Do.
Reporting the Details of 2004
Clinical Trials Using an
Investigational New Animal
Drug in Food-Producing
Animals
------------------------------------------------------------------------
4 Guideline for December Do. Do.
Efficacy Studies for 2004
Systemic Sustained Release
Sulfonamide Boluses for
Cattle
------------------------------------------------------------------------
2 Anthelmintics December Do. Do.
2004
------------------------------------------------------------------------
Guidance Documents Issued by the Office of the Commissioner and the
Office of Policy
------------------------------------------------------------------------
Intended
Date of User or How to Obtain a Copy
Name of Document Issuance Regulatory of the Document
Activity
------------------------------------------------------------------------
FDA Information Sheets for September Regulated Internet via http://
Institutional Review 1998 industry www.fda.gov/oc/ohrt/
Boards and Clinical irbs/default.htm or
Investigators Good Clinical
Practice Programs
(HF-34), Food and
Drug
Administration,
5600 Fishers Lane,
rm. 9C-24,
Rockville, MD
20857, 301-827-
3340, http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/oc/gcp/
for Industry; April Do. Internet via http://
Computerized Systems Used 1999 http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/ora/
in Clinical Trials compliance--ref/
bimo/ffinalcct.pdf
or Good Clinical
Practice Programs
(HF-34), Food and
Drug
Administration,
5600 Fishers Lane,
rm. 9C-24,
Rockville, MD
20857, 301-827-
3340, http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/oc/gcp/
Guidance for March 30, Do. Internet via http://
Institutional Review 2000 http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/ora/
Boards, Clinical compliance--ref/
Investigators, and bimo/err--guide.htm
Sponsors: Exceptions From or Good Clinical
Informed Consent Practice Programs
Requirements for (HF-34), Food and
Emergency Research Drug
Administration,
5600 Fishers Lane,
rm. 9C-24,
Rockville, MD
20857, 301-827-3340
------------------------------------------------------------------------
[[Page 907]]
Draft Guidance for February Do. Internet via http://
Industry on Exports and 1998 www.fda.gov/opacom/
Imports Under the FDA fedregister/
Export Reform and frexport.html
Enhancement Act of 1996
------------------------------------------------------------------------
Guidance for FDA and November FDA Internet via http://
Industry: Direct Final 21, 1997 personnel www.fda.gov/opacom/
Rule Procedures morechoices/
industry/
guidance.htm, or
Office of Policy,
301-827-3360
------------------------------------------------------------------------
International October Regulated 60 FR 53078, October
Harmonization; Policy on 11, 1995 industry 11, 1995; or Office
Standards and FDA of International
personnel Programs, 301-827-
4480
------------------------------------------------------------------------
Guidance Documents Issued by ORA
----------------------------------------------------------------------------------------------------------------
Intended User or How to Obtain a Copy of the Document
Name of Document Date of Issuance Regulatory ---------------------------------------------
Activity Mailing Address Internet Address
----------------------------------------------------------------------------------------------------------------
Compliance Policy Guides Updated December FDA staff National Technical http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/ora/
Manual (replaces Compliance 12, 2003 Information cpgm
Policy Guide--January 1996) Service, 5285 Port
Royal Rd.,
Springfield, VA
22161
----------------------------------------------------------------------------------------------------------------
Compliance Policy Guide, April 2001 Do. Division of http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/ora/
Section 615.115: Extra- Compliance Policy compliance--ref/
Label Use of Medicated (HFC-230), Office revisions.htm
Feeds for Minor Species of Enforcement,
Food and Drug
Administration,
5600 Fishers Lane,
Rockville, MD
20857, 301-827-
0420
----------------------------------------------------------------------------------------------------------------
Compliance Policy Guide, July 2003 Do. Do. Do.
Section 608.400:
Compounding of Drugs for
Use in Animals
----------------------------------------------------------------------------------------------------------------
Compliance Policy Guide, November 14, Do. Do. Do.
Section 555.600: Filth From 2002
Insects, Rodents, and Other
Pests in Foods
----------------------------------------------------------------------------------------------------------------
Compliance Policy Guide, May 29, 2002 Do. Do. Do.
Section 460.200: Pharmacy
Compounding
----------------------------------------------------------------------------------------------------------------
Compliance Policy Guide, May 16, 2002 Do. Do. Do.
Section 575.100: Pesticide
Residues in Food and Feed--
Enforcement Criteria (CPG
7141.01) (revised)
----------------------------------------------------------------------------------------------------------------
Compliance Policy Guide, May 7, 2002 Do. Do. Do.
Section 230.150: Blood
Donor Classification
Statement, Paid or
Volunteer Donor
----------------------------------------------------------------------------------------------------------------
Compliance Policy Guide, October 2001 Do. Do. Do.
Section 510.150: Apple
Juice, Apple Juice
Concentrates, and Apple
Juice Products--
Adulteration With Patulin
----------------------------------------------------------------------------------------------------------------
Compliance Policy Guide, April 2001 Do. Do. Do.
Section 555.250: Statement
of Policy for Labeling and
Preventing Cross-Contact of
Common Food Allergens
----------------------------------------------------------------------------------------------------------------
Compliance Policy Guide, Reformatted Do. Do. http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/ora/
Section 220.100: Interstate March 2001 compliance--ref/cpg/
Shipment of Biological
Products for Use in Medical
Emergencies
----------------------------------------------------------------------------------------------------------------
[[Page 908]]
Compliance Policy Guide, Reformatted Do. Do. Do.
Section 270.100: Final March 2001
Container Labels--
Allergenic Extracts
Containing Glycerin;
Reporting Changes
----------------------------------------------------------------------------------------------------------------
Compliance Policy Guide, December 2000 Do. Do. Do.
Section 230.150: Blood
Donor Incentives; Draft
----------------------------------------------------------------------------------------------------------------
Compliance Policy Guide, July 1991 FDA staff and Do. http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/ora/
Section 7150.09: Fraud, regulated compliance--ref/cpg/
Untrue Statements of industry cpggenl/cpg120-
Material Facts, Bribery, 100.html
and Illegal Gratuities
----------------------------------------------------------------------------------------------------------------
Glossary of Computerized August 1995 Do. National Technical http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/ora/
System and Software Information inspect--ref/igs/
Development Terminology Service, 5285 Port gloss.html
Royal Rd.,
Springfield, VA
22161 (NTIS Order
No. PB96-127352)
----------------------------------------------------------------------------------------------------------------
Guidelines for Entry Review March 12, 1999 FDA staff Division of Import N/A
of Radiation-Emitting Operations and
Electronic Devices Policy (HFC-170),
Office of Regional
Operations, Food
and Drug
Administration,
5600 Fishers Lane,
Rockville, MD
20857, 301-594-
1218
----------------------------------------------------------------------------------------------------------------
Laboratory Procedures Manual June 1994 Do. Division of Field http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/ora/
Science (HFC-141), science--ref/
Food and Drug
Administration,
5600 Fishers Lane,
rm. 12-41,
Rockville, MD
20857
----------------------------------------------------------------------------------------------------------------
Laboratory Procedures May 1999 Do. Do. Do.
Manual; ch. 10: Method
Validation Samples
----------------------------------------------------------------------------------------------------------------
Memorandum: ORA May 15, 2000 Do. Division of Field N/A
Investigational Strategy on Investigations,
Gamma-Butyrolactone (GBL) Office of Regional
and Related Products Operations, Food
and Drug
Administration,
5600 Fishers Lane,
Rockville, MD
20857
----------------------------------------------------------------------------------------------------------------
IOM: Investigations March 2004 Do. National Technical http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/ora/
Operations Manual Information inspect--ref/
Service, 5285 Port
Royal Rd.,
Springfield, VA
22161 (NTIS Order
No. PB2001-913399)
----------------------------------------------------------------------------------------------------------------
Regulatory Procedures Manual March 2004 Do. Do (NTIS Order No. http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/ora/
PB97-196182) compliance--ref/rpm/
default.htm
----------------------------------------------------------------------------------------------------------------
Regulatory Procedures March 2004 Do. Division of Do.
Manual; ch. 5-7-10: Civil Compliance Policy
Money Penalty Reduction (HFC-230), Office
Policy for Small Entities of Enforcement,
Food and Drug
Administration,
5600 Fishers Lane,
Rockville, MD
20857, 301-827-
0420
----------------------------------------------------------------------------------------------------------------
Regulatory Procedures March 2004 Do. Do. Do.
Manual; ch. 10-9:
Application Integrity
Policy
----------------------------------------------------------------------------------------------------------------
[[Page 909]]
Regulatory Procedures September 2002 Do. Do. Do.
Manual; ch. 9: Import
Operations/Actions
----------------------------------------------------------------------------------------------------------------
Regulatory Procedures March 2004 Do. Do. Do.
Manual; ch. 6-1: Seizure
----------------------------------------------------------------------------------------------------------------
Regulatory Procedures March 2004 Do. Do. Do.
Manual; ch. 6-6: Civil
Penalties--Electronic
Product Radiation Control
----------------------------------------------------------------------------------------------------------------
Regulatory Procedures March 2004 Do. Do. http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/ora/
Manual; ch. 4-1: Warning compliance--ref/rpm--
Letters new2/ch4.html
----------------------------------------------------------------------------------------------------------------
Guide to Inspections of Bulk May 1994 Do. National Technical http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/ora/
Pharmaceutical Chemicals Information inspect--ref/igs/
Service, 5285 Port iglist.html
Royal Rd.,
Springfield, VA
22161 (NTIS Order
No. PB96-127154)
----------------------------------------------------------------------------------------------------------------
Guide to Inspections of July 1993 Do. Do (NTIS Order No. Do.
Pharmaceutical Quality PB96-127279)
Control Laboratories
----------------------------------------------------------------------------------------------------------------
Guide to Inspections of July 1993 Do. Do (NTIS Order No. Do.
Microbiological PB96-127287)
Pharmaceutical Quality
Control Laboratories
----------------------------------------------------------------------------------------------------------------
Guide to Inspections of July 1993 Do. Do (NTIS Order No. Do.
Validation of Cleaning PB96-127246)
Processes
----------------------------------------------------------------------------------------------------------------
Guide to Inspections of July 1993 Do. Do (NTIS Order No. Do.
Lyophilization of PB96-127253)
Parenterals
----------------------------------------------------------------------------------------------------------------
Guide to Inspections of High July 1993 Do. Do (NTIS Order No. Do.
Purity Water Systems PB96-127261)
----------------------------------------------------------------------------------------------------------------
Guide to Inspections of October 1993 Do. Do (NTIS Order No. Do.
Dosage Form Drug PB96-127212)
Manufacturers--CGMPs
----------------------------------------------------------------------------------------------------------------
Guide to Inspections of Oral January 1994 Do. Do (NTIS Order No. Do.
Solid Dosage Forms Pre/Post PB96-127345)
Approval Issues for
Development and Validation
----------------------------------------------------------------------------------------------------------------
Guide to Inspections of July 1994 Do. Do (NTIS Order No. Do.
Topical Drug Products PB96-127394)
----------------------------------------------------------------------------------------------------------------
Guide to Inspections of July 1994 Do. Do (NTIS Order No. Do.
Sterile Drug Substance PB96-127295)
Manufacturers
----------------------------------------------------------------------------------------------------------------
Guide to Inspections of Oral August 1994 Do. Do (NTIS Order No. Do.
Solutions and Suspensions PB96-127147)
----------------------------------------------------------------------------------------------------------------
Guide to Nutritional February 1995 Do. Do (NTIS Order No. Do.
Labeling and Education Act PB96-127378)
(NLEA) Requirements
----------------------------------------------------------------------------------------------------------------
Guide to Inspections of April 1995 Do. Do (NTIS Order No. Do.
Interstate Carriers and PB96-127386)
Support Facilities
----------------------------------------------------------------------------------------------------------------
Guide to Inspections of April 1995 Do. Do (NTIS Order No. Do.
Dairy Product Manufacturers PB96-127329)
----------------------------------------------------------------------------------------------------------------
Guide to Inspections of May 1995 Do. Do (NTIS Order No. Do.
Manufacturers of PB97-127220)
Miscellaneous Foods--vol. 1
----------------------------------------------------------------------------------------------------------------
Guide to Inspections of September 1996 Do. Do (NTIS Order No. Do.
Manufacturers of PB97-196133)
Miscellaneous Food
Products--vol. 2
----------------------------------------------------------------------------------------------------------------
[[Page 910]]
Guide to Inspections of February 1995 Do. Do (NTIS Order No. Do.
Cosmetic Product PB96-127238)
Manufacturers
----------------------------------------------------------------------------------------------------------------
Guide to Inspections of Low November 1996 Do. Do (NTIS Order No. Do.
Acid Canned Food PB97-196141)
Manufacturers, Part 1--
Administrative Procedures/
Scheduled Processes
----------------------------------------------------------------------------------------------------------------
Guide to Inspections of Low April 1997 Do. Do (NTIS Order No. Do.
Acid Canned Food PB97-196158)
Manufacturers, Part 2--
Manufacturing Processes/
Procedures
----------------------------------------------------------------------------------------------------------------
Guide to Inspections of Low November 1998 FDA staff Do (NTIS Order No. N/A
Acid Canned Food PB00-133795)
Manufacturers, Part 3--
Container/Closures
----------------------------------------------------------------------------------------------------------------
Guide to Inspections of September 1994 Do. Do (NTIS Order No. http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/ora/
Blood Banks PB96-127303) inspect--ref/igs/
iglist.html
----------------------------------------------------------------------------------------------------------------
Guide to Inspections of Revised April Do. N/A Do.
Source Plasma 2001
Establishments
----------------------------------------------------------------------------------------------------------------
Guide to Inspections of October 1996 Do. National Technical Do.
Infectious Disease Marker Information
Testing Facilities Service, 5285 Port
Royal Rd.,
Springfield, VA
22161 (NTIS Order
No. PB96-199476)
----------------------------------------------------------------------------------------------------------------
Biotechnology Inspection November 1991 Do. Do (NTIS Order No. Do.
Guide Reference Materials PB96-127402)
and Training Aids
----------------------------------------------------------------------------------------------------------------
Guide to Inspection of February 1983 Do. Do (NTIS Order No. Do.
Computerized Systems in PB96-127337)
Drug Processing
----------------------------------------------------------------------------------------------------------------
Guide to Inspections of September 1995 Do. Do (NTIS Order No. Do.
Foreign Medical Device PB96-127311)
Manufacturers
----------------------------------------------------------------------------------------------------------------
Guide to Inspections of May 1996 Do. Do (NTIS Order No. Do.
Foreign Pharmaceutical PB96-199468)
Manufacturers
----------------------------------------------------------------------------------------------------------------
Guide to Inspections of December 1997 Do. Do (NTIS Order No. Do.
Medical Device PB 98-127145 )
Manufacturers
----------------------------------------------------------------------------------------------------------------
Mammography Quality January 1998 Do. Do (NTIS Order No. Do.
Standards Act (MQSA) PB98-127178)
Auditor's Guide
----------------------------------------------------------------------------------------------------------------
Guide to Inspections of December 1997 Do. Do (NTIS Order No. Do.
Electromagnetic PB98-127152)
Compatibility Aspects of
Medical Device Quality
Systems
----------------------------------------------------------------------------------------------------------------
Guide to Inspections of May 1998 Do. N/A Do.
Acidified Food
Manufacturers
----------------------------------------------------------------------------------------------------------------
Guide to Inspection of February 2001 Do. Division of Field N/A
Aseptic Processing and Investigations,
Packaging for the Food Office of Regional
Industry Operations, Food
and Drug
Administration,
5600 Fishers Lane,
Rockville, MD
20857
----------------------------------------------------------------------------------------------------------------
Guide to Inspections of July 2003 Do. Do (NTIS Order No. Do.
Grain Product Manufacturers PB98-137128)
----------------------------------------------------------------------------------------------------------------
Guide to Bioresearch February 1998 Do. Do (NTIS Order No. Do.
Monitoring Inspections of PB98-137151)
In Vitro Diagnostic Devices
----------------------------------------------------------------------------------------------------------------
Guide to Inspections of March 1998 Do. Do (NTIS Order No. Do.
Viral Clearance Processes PB-98137144)
for Plasma Derivatives
----------------------------------------------------------------------------------------------------------------
[[Page 911]]
Guide to Traceback of Fresh April 2001 Do. N/A Do.
Fruits and Vegetables
Implicated in
Epidemiological
Investigations
----------------------------------------------------------------------------------------------------------------
Guide to Inspections of August 1998 Do. National Technical Do.
Computerized Systems in the Information
Food Processing Industry Service, 5285 Port
Royal Rd.,
Springfield, VA
22161 (NTIS Order
No. PB98-137136)
----------------------------------------------------------------------------------------------------------------
Guide to International November 2002 Do. N/A http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/ora/
Inspections and Travel inspect--ref/giit/
(revision) (formerly FDA/ default.htm
ORA International
Inspection Manual and
Travel Guide)
----------------------------------------------------------------------------------------------------------------
Guide to Inspections of August 1999 Do. N/A http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/ora/
Quality Systems inspect--ref/igs/qsit/
QSITGUIDE.PDF
----------------------------------------------------------------------------------------------------------------
Guide to Inspection of Firms August 2001 Do. N/A http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/ora/
Producing Food Products inspect--ref/igs/
Susceptible to iglist.html
Contamination With
Allergenic Ingredients
----------------------------------------------------------------------------------------------------------------
Computerized Systems Used in April 1999 Do. N/A http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/ora/
Clinical Trials compliance--ref/bimo/
----------------------------------------------------------------------------------------------------------------
Compliance Program 7348.001: October 1, 1999 Do. Division of Do.
Bioresearch Monitoring, Compliance Policy
Human Drugs, In Vivo (HFC-230), Office
Bioequivalence of Enforcement,
Food and Drug
Administration,
5600 Fishers Lane,
Rockville, MD
20857, 301-827-
0420
----------------------------------------------------------------------------------------------------------------
Guide for Detecting Fraud in April 2003 Do. Division of Freedom N/A
Bioresearch Monitoring of Information
Inspections (HFI-35), Food and
Drug
Administration,
5600 Fishers Lane,
Rockville, MD
20857
----------------------------------------------------------------------------------------------------------------
Good Laboratory Practice October 1, 2000 Do. Division of http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/ora/
Program 7348.808A Compliance Policy compliance--ref/bimo/
(Nonclinical Laboratories); (HFC-230), Office
EPA Data Audit Inspections of Enforcement,
Food and Drug
Administration,
5600 Fishers Lane,
Rockville, MD
20857, 301-827-
0420
----------------------------------------------------------------------------------------------------------------
Guideline for the Monitoring January 1988 FDA regulated Do. Do.
of Clinical Investigations industry
----------------------------------------------------------------------------------------------------------------
Small Business Guide to FDA Revised March Do. Federal-State http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/ora/
31, 2004 Relations (HFC- fed--state/small--
150), Office of business/sb--guide/
Regulatory default.htm
Affairs, Food and
Drug
Administration,
5600 Fishers Lane,
Rockville, MD
20857, 301-827-
2905
----------------------------------------------------------------------------------------------------------------
Compliance Program 7348.808; Revised February FDA staff Division of http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/ora/
Bioresearch Monitoring, 21, 2001 Compliance Policy compliance--ref/bimo/
Good Laboratory Practice (HFC-230), Office
(Nonclinical Laboratories) of Enforcement,
Food and Drug
Administration,
5600 Fishers Lane,
Rockville, MD
20857, 301-827-
0420
----------------------------------------------------------------------------------------------------------------
[[Page 912]]
Compliance Program 7348.809; October 1, 1994 Do. Do. Do.
Bioresearch Monitoring;
Institutional Review Board
----------------------------------------------------------------------------------------------------------------
Compliance Program 7348.811; October 1, 1997 Do. Do. Do.
Bioresearch Monitoring,
Clinical Investigators
----------------------------------------------------------------------------------------------------------------
Good Laboratory Practice August 1979 Do. Do. Do.
Regulations; Management
Briefings; Post Conference
Report
----------------------------------------------------------------------------------------------------------------
Good Laboratory Practices; June 1981 Do. Do. Do.
Questions and Answers
----------------------------------------------------------------------------------------------------------------
Guidance for FDA Staff on April 4, 2003 FDA staff N/A http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/
Sampling or Detention ohrms/dockets/98fr/03-
Without Physical 8315.pdf
Examination of Decorative
Contact Lenses (Import
Alert 86-10)
----------------------------------------------------------------------------------------------------------------
Compliance Policy Guide; March 29, 2002 FDA staff and Division of http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/ora/
Section 345.100: Male industry Compliance Policy compliance--ref/cpg/
Condom Defects (CPG (HFC-230), Office
7124.21); Draft of Enforcement,
Food and Drug
Administration,
5600 Fishers Lane,
Rockville, MD
20857, 301-827-
0420
----------------------------------------------------------------------------------------------------------------
PTC for Internal Reviews and June 1991 Do. N/A http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/ora/
Corrective Action Operating compliance--ref/aip--
Plans points.html
----------------------------------------------------------------------------------------------------------------
WITHDRAWALS
----------------------------------------------------------------------------------------------------------------
Compliance Policy Guide-- June 15, 1976 FDA staff and N/A
Section 305.100: industry
Acupuncture Devices and
Accessories (CPG 7124.11)
----------------------------------------------------------------------------------------------------------------
Compliance Policy Guide-- October 1, 1980 Do. Do.
Section 396.100:
Applicability of the
Sunlamp Performance
Standard to UVA Tanning
Products (CPG 7133.16)
----------------------------------------------------------------------------------------------------------------
Compliance Policy Guide-- October 1, 1980 Do. Do.
Section 391.100:
Advertisement Literature
for High-Intensity Mercury
Vapor Discharge Lamps (CPG
7133.13)
----------------------------------------------------------------------------------------------------------------
Compliance Policy Guide-- April 26, 1976 Do. Do.
Section 315.200: Status of
Dental Supplies Such As
Denture Cleaners,
Adhesives, Cushions, and
Repair Materials as a
Device or Cosmetic (CPG
7124.05)
----------------------------------------------------------------------------------------------------------------
Compliance Policy Guide-- October 1, 1980 Do. Do.
Section 398.475: Minimum X-
Ray Field Size for Spot-
Film Operation of
Fluoroscopic Systems With
Fixed SID and Without
Stepless Adjustment of the
Field Size (CPG 7133.17)
----------------------------------------------------------------------------------------------------------------
Medical Device Warning March 8, 1999 Do. Do.
Letter Pilot Termination
----------------------------------------------------------------------------------------------------------------
Compliance Policy Guide-- May 13, 1999 Do. Do.
Section 160.850:
Enforcement Policy: 21 CFR
Part 11; Electronic
Records; Electronic
Signatures (CPG 7153.17)
----------------------------------------------------------------------------------------------------------------
Draft Guidance--21 CFR Part August 2002 Do. Do.
11; Electronic Records;
Electronic Signatures,
Electronic Copies of
Electronic Records
----------------------------------------------------------------------------------------------------------------
[[Page 913]]
Draft Guidance--21 CFR Part August 2001 Do. Do.
11; Electronic Records;
Electronic Signatures
Validation
----------------------------------------------------------------------------------------------------------------
Draft Guidance--21 CFR Part August 2001 Do. Do.
11; Electronic Records;
Electronic Signatures,
Glossary of Terms
----------------------------------------------------------------------------------------------------------------
Draft Guidance--21 CFR Part February 2002 Do. Do.
11; Electronic Records;
Electronic Signatures, Time
Stamps
----------------------------------------------------------------------------------------------------------------
Draft Guidance--21 CFR Part July 2002 Do. Do.
11; Electronic Records;
Electronic Signatures,
Maintenance of Electronic
Records
----------------------------------------------------------------------------------------------------------------
Compliance Policy Guide-- February 26, Do. Do.
Section 300.700: Direct 1991
Reference Authority for
Class III Medical Devices
Without a Premarket
Notification (510(k)) or an
Approved Premarket Approval
Application (PMA) (CPG
7124.30)
----------------------------------------------------------------------------------------------------------------
Compliance Policy Guide-- October 1, 1980 Do. Do.
Section 405.100:
Prescriptions Prepared From
Certified Antibiotics (CPG
7122.01)
----------------------------------------------------------------------------------------------------------------
Compliance Policy Guide-- October 1, 1980 Do. Do.
Section 405.200: Export of
Uncertified Antibiotics
(CPG 7122.02)
----------------------------------------------------------------------------------------------------------------
Compliance Policy Guide-- July 1, 1981 Do. Do.
Section 405.210: Returned
Antibiotics Exported Under
801(d) of the Act (CPG
7122.03)
----------------------------------------------------------------------------------------------------------------
Draft Compliance Policy August 28, 1997 Do. Do.
Guide--Distributor Medical
Device Reporting
----------------------------------------------------------------------------------------------------------------
Dated: December 22, 2004.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-155 Filed 1-4-05; 8:45 am]
BILLING CODE 4160-01-S