[Federal Register: July 9, 2004 (Volume 69, Number 131)]
[Notices]
[Page 41510-41540]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr09jy04-100]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2004N-0234]
Annual Guidance Agenda
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is publishing its
annual guidance document agenda. FDA committed to publishing, on an
annual basis, a list of possible topics for future guidance document
development or revision during the next year, and seeking public
comment on additional ideas for new guidance documents or revisions of
existing ones. This commitment was made in FDA's September 2000 good
guidance practices (GGPs) final rule, which sets forth the agency's
policies and procedures for the development, issuance, and use of
guidance documents. This list is intended to seek public comment on
possible topics for guidance documents and possible revisions to
existing guidances.
DATES: Submit written or electronic 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
.
FOR FURTHER INFORMATION CONTACT:
For general information regarding this list contact: Diane
Sullivan, Office of Policy (HF-26), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-827-3480.
For information regarding specific topics or guidances: Please see
contact persons listed in the table in the SUPPLEMENTARY INFORMATION
section.
SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register of September 19, 2000 (65 FR 56468), FDA
published a final rule announcing its GGPs, which set forth the
agency's policies and procedures for the development, issuance, and use
of guidance documents. The agency adopted the GGPs to ensure public
involvement in the development of guidance documents and to enhance
public understanding of the availability, nature, and legal effect of
such guidance.
As part of FDA's effort to ensure meaningful interaction with the
public regarding guidance documents, the agency committed to publishing
an annual guidance document agenda of possible guidance topics or
documents for development or revision during the coming year. The
agency also committed to soliciting public input regarding these and
additional ideas for new topics or revisions to existing guidance
documents (65 FR 56468 at 56477, 21 CFR 10.115(f)(5)).
The agency is neither bound by this list of possible topics nor
required to issue every guidance document on this list or precluded
from issuing guidance documents not on the list set forth in this
document.
The following list of guidance topics or documents represents
possible new topics or revisions to existing guidance documents that
the agency is considering. The agency solicits comments on the topics
listed in this document and also seeks additional ideas from the
public.
The guidance documents are organized by the issuing center or
office within FDA, and are further grouped by topic categories. The
agency's contact persons are listed for each specific area in the
table.
----------------------------------------------------------------------------------------------------------------
Title/Topic of Guidance Contact
----------------------------------------------------------------------------------------------------------------
II. CENTER FOR BIOLOGICS EVALUATION AND RESEARCH (CBER)
¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬
CATEGORY--COMPLIANCE AND INSPECTION
================================================================================================================
Reprocessing, Reworking, and Blending of Biological Drug Stephen M. Ripley, Center for Biologics
Substances and Drug Products Evaluation and Research (HFM-17), Food
and Drug Administration, 1401 Rockville
Pike, Rockville, MD 20852-1448, 301-827-
6210.
----------------------------------------------------------------------------------------------------------------
[[Page 41511]]
Design, Installation and Operation of Heating, Ventilation and Air Same as above (Do)
Conditioning Systems Used in the Manufacture of Products
Regulated by the Center for Biologics Evaluation and Research and
the Center for Drug Evaluation and Research
----------------------------------------------------------------------------------------------------------------
Compliance Program 7341.002--Inspection of Tissue Establishments Do
----------------------------------------------------------------------------------------------------------------
Compliance Program 7342.001--Inspection of Licensed and Unlicensed Do
Blood Banks, Brokers, Reference Laboratories, and Contractors
----------------------------------------------------------------------------------------------------------------
Compliance Program 7342.002--Inspection of Source Plasma Do
Establishments
----------------------------------------------------------------------------------------------------------------
Compliance Program 7342.008--Inspections of Licensed Viral Marker Do
Test Kits
----------------------------------------------------------------------------------------------------------------
Compliance Program 7345.001--Inspection of Center for Biologics Do
Evaluation and Research-Regulated Biological Drug Products
================================================================================================================
CATEGORY--CELLULAR, TISSUE, AND GENE THERAPY
================================================================================================================
Submission of Information for the National Xenotransplantation Do
Database
----------------------------------------------------------------------------------------------------------------
Guidance for Reviewers: Instructions and Template for Chemistry, Do
Manufacturing, and Controls Reviewers of Human Gene Therapy
Investigational New Drug Applications
----------------------------------------------------------------------------------------------------------------
Submission of Information for Adverse Event and Annual Reports for Do
Gene Therapy Investigational New Drug Applications
----------------------------------------------------------------------------------------------------------------
Eligibility Determination for Donors of Human Cells, Tissue and Do
Cellular and Tissue-Based Products
================================================================================================================
CATEGORY--BLOOD AND BLOOD COMPONENTS
================================================================================================================
Blood Establishment Software Do
----------------------------------------------------------------------------------------------------------------
Collection of Platelets, Pheresis Prepared by Automated Methods Do
----------------------------------------------------------------------------------------------------------------
Validation of the Computer Crossmatch Do
----------------------------------------------------------------------------------------------------------------
Blood Contact Materials Do
----------------------------------------------------------------------------------------------------------------
Nucleic Acid Testing for Human Immunodeficiency Virus and Do
Hepatitis C Virus; Testing, Product Disposition, Donor Deferral
and Re-entry
----------------------------------------------------------------------------------------------------------------
Efficacy, Pharmokinetic, and Safety Studies to Support Marketing Do
of Immune Globulin Intravenous (Human) as a Replacement Therapy
for Primary Humoral Immunodeficiency
----------------------------------------------------------------------------------------------------------------
Guidance on the Content of Premarket Submissions for Center for Do
Biologics Evaluation and Research-Regulated Automated Instruments
and Associated Software Systems for Donor Blood Collection and
Screening
================================================================================================================
CATEGORY--VACCINES
================================================================================================================
Characterization and Qualification of Cell Substances and Viral Do
Seeds Used to Produce Viral Vaccines
----------------------------------------------------------------------------------------------------------------
Preclinical Toxicity Studies for Prophylactic Vaccines Do
----------------------------------------------------------------------------------------------------------------
Immunization Human Plasma Donors to Obtain Source Plasma for Do
Preparation of Specific Immune Globulins
----------------------------------------------------------------------------------------------------------------
Content and Format of Chemistry, Manufacturing, and Controls Do
Information and Establishment Description Information for a
Vaccine or Related Product
----------------------------------------------------------------------------------------------------------------
Content and Format of Chemistry, Manufacturing, and Controls Do
Information and Establishment Description Information for an
Allergenic Extract or Allergen Patch Test
================================================================================================================
CATEGORY--OTHER
================================================================================================================
Providing Regulatory Submission in Electronic Format--Stability Do
----------------------------------------------------------------------------------------------------------------
Environmental Assessment/National Environmental Policy Act Do
----------------------------------------------------------------------------------------------------------------
Filing and Application When the Applicant Protests a Refusal to Do
File Action
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[[Page 41512]]
Multi-Product Manufacturing With Spore-Forming Microorganisms Do
----------------------------------------------------------------------------------------------------------------
Good Review Practices--Track IV Do
----------------------------------------------------------------------------------------------------------------
Submission of Chemistry, Manufacturing, and Controls and Do
Establishment Description Information for Human Plasma-Derived
Biological Products, Animal Plasma or Serum-Derived Products
----------------------------------------------------------------------------------------------------------------
Submission of Chemistry, Manufacturing, and Control Information Do
for a Therapeutic Recombinant Deoxyribonucleic Acid-Derived
Product or a Monoclonal Antibody for In-Vivo Use
¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬
III. CENTER FOR DEVICES AND RADIOLOGICAL HEALTH
¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬
Implementation of the Inspection by Accredited Persons Program John F. Stigi, Center for Devices and
Under the Medical Device User Fee and Modernization Act of 2002; Radiological Health (HFZ-220), Food and
Accreditation Criteria: Guidance for Industry, FDA Staff and Drug Administration, 9200 Corporate
Third Parties Blvd., Rockville, MD 20850, 301-443-0806
----------------------------------------------------------------------------------------------------------------
Implementation of Third Party Programs Under the FDA Modernization Do
Act of 1997; Final Guidance for Staff, Industry, and Third
Parties
----------------------------------------------------------------------------------------------------------------
Mutual Recognition Agreement Between the European Union and the Christine Nelson, Center for Devices and
United States of America: Confidence Building Programme: Overview Radiological Health (HFZ-220), Food and
and Procedure; Medical Device Annex, Version 7, June 29, 2000; Drug Administration, 9200 Corporate
Draft Blvd., Rockville, MD 20850, 301-443-0806
----------------------------------------------------------------------------------------------------------------
Regulation of Medical Devices; Background Information for Ron Parr, Center for Devices and
International Officials (Entire Document Available on Disk) Radiological Health (HFZ-220), Food and
Drug Administration, 9200 Corporate
Blvd., Rockville, MD 20850, 301-443-0806
----------------------------------------------------------------------------------------------------------------
Guidance for Staff, Industry, and Third Parties: Third Party John F. Stigi, Center for Devices and
Programs Under the Sectoral Annex on Medical Devices to the Radiological Health (HFZ-220), Food and
Agreement on Mutual Recognition Between the United States of Drug Administration, 9200 Corporate
America and the European Community Blvd., Rockville, MD 20850, 301-443-0806
----------------------------------------------------------------------------------------------------------------
Medical Device Appeals and Complaints: A Guidance on Dispute Do
Resolution
----------------------------------------------------------------------------------------------------------------
Overview of Food and Drug Administration Modernization Act of 1997 Do
Medical Device Provisions (Food and Drug Administration
Modernization Act)
----------------------------------------------------------------------------------------------------------------
Medical Device Reporting for Manufacturers Do
----------------------------------------------------------------------------------------------------------------
In Vitro Diagnostic Devices: Guidance for the Preparation of Do
Premarket Notification Submissions (FDA 97-4224)
----------------------------------------------------------------------------------------------------------------
Medical Device Quality Systems Manual: A Small Entity Compliance Do
Guide
----------------------------------------------------------------------------------------------------------------
Comparison Chart: 1996 Quality System Reg vs. 1978 Good Do
Manufacturing Practices Reg vs. ANSI/ISO/ASQC Q9001 and ISO/DI
13485:1996 (Include 126)
----------------------------------------------------------------------------------------------------------------
Premarket Notification: 510(k)--Regulatory Requirements for Do
Medical Devices (FDA 95-4158)
----------------------------------------------------------------------------------------------------------------
Labeling--Regulatory Requirements for Medical Devices (FDA 89- Paula G. Silberberg, Center for Devices
4203) and Radiological Health (HFZ-230), Food
and Drug Administration, 9200 Corporate
Blvd., Rockville, MD 20850, 301-594-1217
----------------------------------------------------------------------------------------------------------------
Impact Resistant Lenses: Questions and Answers (FDA 87-4002) Do
----------------------------------------------------------------------------------------------------------------
Use of Symbols on Labels and in Labeling of In Vitro Diagnostic Lily Ng, Center for Devices and
Devices Intended for Professional Use (Draft) Radiological Health (HFZ-510), Food and
Drug Administration, 9200 Corporate
Blvd., Rockville, MD 20850, 301-827-0885
----------------------------------------------------------------------------------------------------------------
Frequently Asked Questions About the Reprocessing and Reuse of Do
Single-Use Devices by Third-Party and Hospital Reprocessors;
Three Additional Questions
----------------------------------------------------------------------------------------------------------------
Frequently Asked Questions About the Reprocessing and Reuse of Paula G. Silberberg, Center for Devices
Single-Use Devices by Third-Party and Hospital Reprocessors; and Radiological Health (HFZ-230), Food
Final Guidance for Industry and FDA Staff and Drug Administration, 9200 Corporate
Blvd., Rockville, MD 20850, 301-594-1217
----------------------------------------------------------------------------------------------------------------
[[Page 41513]]
Guidance on Medical Device Patient Labeling; Final Guidance for Do
Industry and FDA Reviewers
----------------------------------------------------------------------------------------------------------------
Center for Devices and Radiological Health Manual for the Good Ron D. Kaye, Center for Devices and
Guidance Practices Regulations; Final Guidance for FDA Staff Radiological Health (HFZ-205), Food and
Drug Administration, 9200 Corporate
Blvd., Rockville, MD 20850, 301-594-3265
----------------------------------------------------------------------------------------------------------------
Medical Device Use--Safety: Incorporating Human Factors Center for Devices and Radiological Health
Engineering Into Risk Management; Guidance for Industry and FDA (HFZ-230), Food and Drug Administration,
Premarket and Design Control Reviewers 9200 Corporate Blvd., Rockville, MD
20850, 301-594-1217
----------------------------------------------------------------------------------------------------------------
Human Factors Points to Consider for Investigational Device Alvin W. Thomas, Center for Devices and
Exemption Devices Radiological Health (HFZ-230), Food and
Drug Administration, 9200 Corporate
Blvd., Rockville, MD 20850, 301-443-2436
----------------------------------------------------------------------------------------------------------------
Do It By Design--An Introduction to Human Factors in Medical Walter l. Scott, Center for Devices and
Devices Radiological Health (HFZ-240), Food and
Drug Administration, 9200 Corporate
Blvd., Rockville, MD 20850, 301-594-3266
----------------------------------------------------------------------------------------------------------------
Medical Device Reporting for User Facilities Margaret T. Tolbert, Center for Devices
and Radiological Health (HFZ-230), Food
and Drug Administration, 9200 Corporate
Blvd., Rockville, MD 20850, 301-443-2436
----------------------------------------------------------------------------------------------------------------
Human Factors Principles for Medical Device Labeling Center for Devices and Radiological Health
(HFZ-230), Food and Drug Administration,
9200 Corporate Blvd., Rockville, MD
20850, 301-594-1217
----------------------------------------------------------------------------------------------------------------
Write It Right Charles A. Finder, Center for Devices and
Radiological Health (HFZ-240), Food and
Drug Administration, 9200 Corporate
Blvd., Rockville, MD 20850, 301-594-3332
----------------------------------------------------------------------------------------------------------------
The Mammography Quality Standards Act Final Regulations Do
Modifications and Additions to Policy Guidance Help System < greek-
i>8 (Incorporated into Policy Guidance Help Systems)
----------------------------------------------------------------------------------------------------------------
The Mammography Quality Standards Act Final Regulations Do
Modifications and Additions to Policy Guidance Help System < greek-
i>6; Guidance for Industry and FDA (Incorporated into Policy
Guidance Help System)
----------------------------------------------------------------------------------------------------------------
The Mammography Quality Standards Act Final Regulations Do
Modifications and Additions to Policy Guidance Help System < greek-
i>7; Guidance for Industry and FDA (Incorporated into Policy
Guidance Help System)
----------------------------------------------------------------------------------------------------------------
The Mammography Quality Standards Act Final Regulations Do
Modifications and Additions to Policy Guidance Help System < greek-
i>5; Guidance for Industry and FDA (Incorporated into Policy
Guidance Help System)
----------------------------------------------------------------------------------------------------------------
The Mammography Quality Standards Act Final Regulations Do
Modifications and Additions to Policy Guidance Help System < greek-
i>4; Guidance for Industry and FDA (Incorporated into Policy
Guidance Help System)
----------------------------------------------------------------------------------------------------------------
Compliance Guidance--The Mammography Quality Standards Act Final Do
Regulations--Preparing for Mammography Quality Standards Act
Inspections (Incorporated into Policy Guidance Help System)
----------------------------------------------------------------------------------------------------------------
The Mammography Quality Standards Act Final Regulations Do
Modifications and Additions to Policy Guidance Help System < greek-
i>3; Guidance for Industry and FDA (Incorporated into Policy
Guidance Help System)
----------------------------------------------------------------------------------------------------------------
The Mammography Quality Standards Act Final Regulations Do
Modifications to the Policy Guidance Help System Due to the
September 11, 2001, Terrorist Attacks; Final Guidance for
Industry and FDA (Incorporated into Policy Guidance Help System)
----------------------------------------------------------------------------------------------------------------
The Mammography Quality Standards Act Final Regulations Do
Modifications and Additions to Policy Guidance Help System < greek-
i>4; Guidance for Industry and FDA (Incorporated into Policy
Guidance Help System)
----------------------------------------------------------------------------------------------------------------
[[Page 41514]]
The Mammography Quality Standards Act Final Regulations; Do
Modifications and Additions to Policy Guidance Help System < greek-
i>2; Final Guidance for Industry and FDA (Incorporated into
Policy Guidance Help System)
----------------------------------------------------------------------------------------------------------------
Compliance Guidance--Mammography Facility Survey, Equipment Do
Evaluation and Medical Physicist Qualification Requirements Under
MQSA; Final (Incorporated into Policy Guidance Help System)
----------------------------------------------------------------------------------------------------------------
Compliance Guidance: The Mammography Quality Standards Act Final Do
Regulations Document 3 (Incorporated into Policy
Guidance Help System)
----------------------------------------------------------------------------------------------------------------
The Mammography Quality Standards Act Final Regulations Do
Modifications to the Policy Guidance Help System 1;
Guidance for Industry and FDA (Incorporated into Policy Guidance
Help System)
----------------------------------------------------------------------------------------------------------------
Compliance Guidance: The Mammography Quality Standards Act Final Do
Regulations Document 2 (Incorporated into Policy
Guidance Help System)
----------------------------------------------------------------------------------------------------------------
Compliance Guidance: The Mammography Quality Standards Act Final Do
Regulations Quality Assurance Documentation (Incorporated into
Policy Guidance Help System)
----------------------------------------------------------------------------------------------------------------
Guidance for Request and Issuance of Interim Notice Letters for Do
Mammography Facilities Under the Mammography Quality Standards
Act (42 U.S.C. 263(b)) (Incorporated into Policy Guidance Help
System)
----------------------------------------------------------------------------------------------------------------
Compliance Guidance: The Mammography Quality Standards Act Final Do
Regulations Motion of Tube-Image Receptor Assembly (Incorporated
into Policy Guidance Help System)
----------------------------------------------------------------------------------------------------------------
Guidance: The Mammography Quality Standards Act Final Regulations Do
Document 1 (Incorporated into Policy Guidance Help
System)
----------------------------------------------------------------------------------------------------------------
Guidance for Industry--Requalification for Interpreting Do
Physician's Continuing Experience Requirement (Incorporated into
Policy Guidance Help System)
----------------------------------------------------------------------------------------------------------------
Policy and Standard Operating Procedures When Mammography Do
Facilities in States That Have Accreditation Bodies Intend to
Change Accreditation Bodies (Incorporated into Policy Guidance
Help System)
----------------------------------------------------------------------------------------------------------------
Guidance for Review of Requests for Reconsideration of Adverse Paula G. Silberberg, Center for Devices
Decisions on Accreditation of Mammography Facilities Under the and Radiological Health (HFZ-230), Food
Mammography Quality Standards Act (42 U.S.C. 263(b)) (April 8, and Drug Administration, 9200 Corporate
1998) (Incorporated into Policy Guidance Help System) Blvd., Rockville, MD 20850, 301-594-1217
----------------------------------------------------------------------------------------------------------------
Guidance for Submission of Request for Reconsideration of Adverse Do
Decisions on Accreditation of Mammography Facilities Under the
Mammography Quality Standards Acts (42 U.S.C. 263(b)) (April 8,
1998) (Incorporated into Policy Guidance Help System)
----------------------------------------------------------------------------------------------------------------
Continuing Education Credit for Reading/Writing Articles/Papers Do
and Presenting Courses/Lectures (Incorporated into the Policy
Guidance Help System)
----------------------------------------------------------------------------------------------------------------
Accidental Radioactive Contamination of Human Food and Animal Thomas E. Cardamone, Center for Devices
Feeds: Recommendations to State and Local Agencies and Radiological Health (HFZ-220), Food
and Drug Administration, 9200 Corporate
Blvd., Rockville, MD 20850, 301-443-0806,
ext. 117
================================================================================================================
Office of Device Evaluation
================================================================================================================
Fiscal Year 2004 MDUFMA Small Business Qualification Worksheet and Joanne R. Less, Center for Devices and
Certification--Guidance for Industry and FDA Radiological Health (HFZ-403), Food and
Drug Administration, 9200 Corporate
Blvd., Rockville, MD 20850, 301-594-1190
----------------------------------------------------------------------------------------------------------------
Premarket Assessment of Pediatric Medical Devices--Draft Guidance Heather S. Rosecrans, Center for Devices
for Industry and FDA Staff and Radiological Health (HFZ-230), Food
and Drug Administration, 9200 Corporate
Blvd., Rockville, MD 20850, 301-594-1190
----------------------------------------------------------------------------------------------------------------
Pediatric Expertise for Advisory Panels--Guidance for Industry and Joanne R. Less, Center for Devices and
FDA Staff Radiological Health (HFZ-403), Food and
Drug Administration, 9200 Corporate
Blvd., Rockville, MD 20850, 301-594-1190
----------------------------------------------------------------------------------------------------------------
[[Page 41515]]
Premarket Approval Application Filing Review--Guidance for Center for Devices and Radiological Health
Industry and FDA Staff (HFZ-403), Food and Drug Administration,
9200 Corporate Blvd., Rockville, MD
20850, 301-594-1190
----------------------------------------------------------------------------------------------------------------
Guidance for Industry and FDA: Fiscal Year 2003 MDUFMA Small Do
Business Qualification Worksheet and Certification
----------------------------------------------------------------------------------------------------------------
Assessing User Fees: Premarket Approval Application Supplement Do
Definitions, Modular Premarket Approval Application Fees,
Biologics License Application and Efficacy Supplement
Definitions, Bundling Multiple Devices in a Single Application,
and Fees for Combination Products
----------------------------------------------------------------------------------------------------------------
Determination of Intended Use for 510(k) Devices; Guidance for Do
Center for Devices and Radiological Health Staff
----------------------------------------------------------------------------------------------------------------
The Least Burdensome Provisions of the FDA Modernization Act of Thninh Nguyen, Center for Devices and
1997: Concept and Principles: Final Guidance for FDA and Industry Radiological Health (HFZ-402), Food and
Drug Administration, 9200 Corporate
Blvd., Rockville, MD 20850, 301-594-2186
----------------------------------------------------------------------------------------------------------------
Updated 510(k) Sterility Review Guidance K90-1; Final Guidance for Robert R. Gatling, Center for Devices and
Industry and FDA Radiological Health (HFZ-402), Food and
Drug Administration, 9200 Corporate
Blvd., Rockville, MD 20850, 301-594-1190
----------------------------------------------------------------------------------------------------------------
Availability of Information Given to Advisory Committee Members in Nancy J. Pluhowski, Center for Devices and
Connection With Center for Devices and Radiological Health Open Radiological Health (HFZ-400), Food and
Public Panel Meetings; Draft Guidance for Industry and FDA Staff Drug Administration, 9200 Corporate
Blvd., Rockville, MD 20850, 301-594-2022
----------------------------------------------------------------------------------------------------------------
Humanitarian Device Exemptions Regulation: Questions and Answers; Heather S. Rosecrans, Center for Devices
Final Guidance for Industry and Radiological Health (HFZ-230), Food
and Drug Administration, 9200 Corporate
Blvd., Rockville, MD 20850, 301-594-1190
----------------------------------------------------------------------------------------------------------------
Changes or Modifications During the Conduct of a Clinical Donna-Bea Tillman, Center for Devices and
Investigation; Final Guidance for Industry and Center for Devices Radiological Health (HFZ-400), Food and
and Radiological Health Staff Drug Administration, 9200 Corporate
Blvd., Rockville, MD 20850, 301-594-2022
----------------------------------------------------------------------------------------------------------------
Early Collaboration Meetings Under the FDA Modernization Act; Do
Final Guidance for Industry and for Center for Devices and
Radiological Health Staff
----------------------------------------------------------------------------------------------------------------
Deciding When to Submit a 510(k) for a Change to an Existing Karen F. Warbuton, Center for Devices and
Wireless Telemetry Medical Device; Final Guidance for FDA Radiological Health (HFZ-460), Food and
Reviewers and Industry Drug Administration, 9200 Corporate
Blvd., Rockville, MD 20850, 301-594-1744
----------------------------------------------------------------------------------------------------------------
Guidance on Section 216 of the Food and Drug Administration Nicole Wolanski, Center for Devices and
Modernization Act of 1997 Radiological Health (HFZ-402), Food and
Drug Administration, 9200 Corporate
Blvd., Rockville, MD 20850, 301-594-2186
----------------------------------------------------------------------------------------------------------------
Guidance on Amended Procedures for Advisory Panel Meetings; Final Daniel G. Schultz, Center for Devices and
Radiological Health (HFZ-400), Food and
Drug Administration, 9200 Corporate
Blvd., Rockville, MD 20850, 301-594-2022
----------------------------------------------------------------------------------------------------------------
Guidance on the Use of Standards in Substantial Equivalence Heather S. Rosecrans, Center for Devices
Determinations; Final and Radiological Health (HFZ-230), Food
and Drug Administration, 9200 Corporate
Blvd., Rockville, MD 20850, 301-594-1190
----------------------------------------------------------------------------------------------------------------
Guidance for Off-the-Shelf Software Use in Medical Devices; Final Joanna H. Weitershausen, Center for
Devices and Radiological Health (HFZ-
480), Food and Drug Administration, 9200
Corporate Blvd., Rockville, MD 20850, 301-
443-8611
----------------------------------------------------------------------------------------------------------------
Medical Devices Containing Materials Derived From Animal Sources Nicole Wolanski, Center for Devices and
(Except In Vitro Diagnostic Devices), Guidance for FDA Reviewers Radiological Health (HFZ-402), Food and
and Industry; Final Drug Administration, 9200 Corporate
Blvd., Rockville, MD 20850, 301-594-2186
----------------------------------------------------------------------------------------------------------------
[[Page 41516]]
Premarket Approval Application Modular Review Philip J. Phillips, Center for Devices and
Radiological Health (HFZ-400), Food and
Drug Administration, 9200 Corporate
Blvd., Rockville, MD 20850, 301-594-2022
----------------------------------------------------------------------------------------------------------------
Guidance for Industry; General/Specific Intended Use; Final Thninh Nguyen, Center for Devices and
Radiological Health (HFZ-402), Food and
Drug Administration, 9200 Corporate
Blvd., Rockville, MD 20850, 301-594-2186
----------------------------------------------------------------------------------------------------------------
Frequently Asked Questions on the New 510(k) Paradigm; Final Do
----------------------------------------------------------------------------------------------------------------
Guidance for the Content of Premarket Submissions for Software Do
Contained in Medical Devices; Final
----------------------------------------------------------------------------------------------------------------
Guidance to Industry Supplements to Approved Applications for Do
Class III Medical Devices: Use of Published Literature, Use of
Previously Submitted Materials, and Priority Review; Final
----------------------------------------------------------------------------------------------------------------
A New 510(k) Paradigm--Alternate Approaches to Demonstrating Do
Substantial Equivalence in Premarket Notifications
----------------------------------------------------------------------------------------------------------------
Guidance for Industry and FDA Staff: Expedited Review of Premarket Joanne R. Less, Center for Devices and
Submissions for Devices Radiological Health (HFZ-403), Food and
Drug Administration, 9200 Corporate
Blvd., Rockville, MD 20850, 301-594-1190
----------------------------------------------------------------------------------------------------------------
PMA/510(k) Expedited Review G94-4 (blue book memo) Thninh Nguyen, Center for Devices and
Radiological Health (HFZ-402), Food and
Drug Administration, 9200 Corporate
Blvd., Rockville, MD 20850, 301-594-2186
----------------------------------------------------------------------------------------------------------------
30-Day Notices and 135-Day Premarket Approval Application Heather S. Rosecrans, Center for Devices
Supplements for Manufacturing Method or Process Changes, Guidance and Radiological Health (HFZ-230), Food
for Industry and Center for Devices and Radiological Health and Drug Administration, 9200 Corporate
(Docket 98D-0080); Final Blvd., Rockville, MD 20850, 301-594-1190
----------------------------------------------------------------------------------------------------------------
Guidance on Premarket Approval Application Interactive Procedures Thninh Nguyen, Center for Devices and
for Day-100 Meetings and Subsequent Deficiencies--for Use by Radiological Health (HFZ-402), Food and
Center for Devices and Radiological Health and Industry; Final Drug Administration, 9200 Corporate
Blvd., Rockville, MD 20850, 301-594-2186
----------------------------------------------------------------------------------------------------------------
New Section 513(f)(2)--Evaluation of Automatic Class III Do
Designation: Guidance for Industry and Center for Devices and
Radiological Health Staff; Final
----------------------------------------------------------------------------------------------------------------
Procedures for Class II Device Exemptions From Premarket Do
Notification Guidance for Industry and Center for Devices and
Radiological Health Staff; Final
----------------------------------------------------------------------------------------------------------------
Guidance on Investigational Device Exemption Policies and Heather S. Rosecrans, Center for Devices
Procedures; Final and Radiological Health (HFZ-230), Food
and Drug Administration, 9200 Corporate
Blvd., Rockville, MD 20850, 301-594-1190
----------------------------------------------------------------------------------------------------------------
Distribution and Public Availability of Premarket Approval Do
Application Summary of Safety and Effectiveness Data Packages
----------------------------------------------------------------------------------------------------------------
Kit Certification for Premarket Notifications Do
----------------------------------------------------------------------------------------------------------------
Convenience Kits Interim Regulatory Guidance Do
----------------------------------------------------------------------------------------------------------------
Real-Time Review Program for Premarket Approval Application Do
Supplements
----------------------------------------------------------------------------------------------------------------
Deciding When to Submit a Premarket Notification for a Change to Do
an Existing Device (K97-1)
----------------------------------------------------------------------------------------------------------------
Questions and Answers for the FDA Reviewer Guidance: Labeling Do
Reusable Medical Devices for Reprocessing in Health Care
Facilities
----------------------------------------------------------------------------------------------------------------
Memorandum of Understanding Regarding Patient Labeling Review Do
(blue book memo G96-3)
----------------------------------------------------------------------------------------------------------------
Continued Access to Investigational Devices During Premarket Do
Approval Application Preparation and Review (blue book memo) (D96-
1)
----------------------------------------------------------------------------------------------------------------
[[Page 41517]]
Format for Investigational Device Exemption Progress Reports Do
----------------------------------------------------------------------------------------------------------------
Labeling Reusable Medical Devices for Reprocessing in Health Care Do
Facilities: FDA Reviewer Guidance
----------------------------------------------------------------------------------------------------------------
Premarket Notification Quality Review Program (blue book memo) Do
----------------------------------------------------------------------------------------------------------------
Suggested Content for Original Investigational Device Exemption Do
Application Cover Letter
----------------------------------------------------------------------------------------------------------------
Indications for Use Statement Do
----------------------------------------------------------------------------------------------------------------
Cover Letter: Premarket Notification Requirements During Firm- Do
Initiated Recalls; Attachment A: Guidance on Recall and Premarket
Notification Review Procedures During Firm-Initiated Recalls of
Legally Marketed Devices (blue book memo K95-1)
----------------------------------------------------------------------------------------------------------------
D95-2, Attachment A (Interagency Agreement Between FDA & Do
Health Care Financing Administration
----------------------------------------------------------------------------------------------------------------
D95-2, Attachment B (Criteria for Categorization of Do
Investigational Devices Health Care Financing Administration
----------------------------------------------------------------------------------------------------------------
Health Care Financing Administration Reimbursement Categorization Do
Determinations for FDA-Approved Investigational Device Exemptions
----------------------------------------------------------------------------------------------------------------
Implementation of the FDA/Health Care Financing Administration Do
Interagency Agreement Regarding Reimbursement Categorization of
Investigational Devices, Attachment A Interagency Agreement,
Attachment B Criteria for Categorization of Investigational
Devices, and Attachment C -List D95-2 (blue book memo)
----------------------------------------------------------------------------------------------------------------
Goals and Initiatives for the Investigational Device Exemption Joanne R. Less, Center for Devices and
Program D95-1 (blue book memo) Radiological Health (HFZ-403), Food and
Drug Administration, 9200 Corporate
Blvd., Rockville, MD 20850, 301-594-1190
----------------------------------------------------------------------------------------------------------------
Memorandum: Electromagnetic Compatibility for Medical Devices: Heather S. Rosecrans, Center for Devices
Issues and Solutions and Radiological Health (HFZ-230), Food
and Drug Administration, 9200 Corporate
Blvd., Rockville, MD 20850, 301-594-1190
----------------------------------------------------------------------------------------------------------------
Use of International Standard ISO-10993, `Biological Evaluation of Do
Medical Devices Part 1: Evaluation and Testing7rsquo; (Replaces
G87-1 8294) (blue book memo)
----------------------------------------------------------------------------------------------------------------
Premarket Approval Application Closure P94-2 (blue book Do
memo)
----------------------------------------------------------------------------------------------------------------
Premarket Notification Sign-Off Procedures K94-2 (blue Do
book memo)
----------------------------------------------------------------------------------------------------------------
Letter to Industry, Powered Wheelchair/Scooter or Accessory/ Do
Component Manufacturer From Susan Alpert
----------------------------------------------------------------------------------------------------------------
Premarket Notification Refuse to Accept Procedures K94-1 Do
(blue book memo)
----------------------------------------------------------------------------------------------------------------
Investigational Device Exemption Refuse to Accept Procedures Do
D94-1 (blue book memo)
----------------------------------------------------------------------------------------------------------------
Preamendments Class III Strategy Premarket Notification Status Do
Request Form
----------------------------------------------------------------------------------------------------------------
Documentation and Resolution of Differences of Opinion on Product Do
Evaluations G93-1 (blue book memo)
----------------------------------------------------------------------------------------------------------------
Premarket Notification Additional Information Procedures < greek- Do
i>K93-1 (blue book memo)
----------------------------------------------------------------------------------------------------------------
Center for Devices and Radiological Health's Investigational Do
Device Exemption Refuse to Accept Policy
----------------------------------------------------------------------------------------------------------------
Center for Devices and Radiological Health's Premarket Do
Notification Refuse to Accept Policy--(Updated Checklist for
March 14, 1995)
----------------------------------------------------------------------------------------------------------------
Classified Convenience Kits Do
----------------------------------------------------------------------------------------------------------------
Telephone Communications Between Office of Device Evaluation Staff Do
and Manufacturers I93-1 (blue book memo)
----------------------------------------------------------------------------------------------------------------
Preamendment Class III Devices Do
----------------------------------------------------------------------------------------------------------------
[[Page 41518]]
Nondisclosure of Financially Sensitive Information I92-1 Do
(blue book memo)
----------------------------------------------------------------------------------------------------------------
Document Review Processing I91-1 (blue book memo) Do
----------------------------------------------------------------------------------------------------------------
Integrity of Data and Information Submitted to Office of Device Do
Evaluation I91-2 (blue book memo)
----------------------------------------------------------------------------------------------------------------
Panel Review of Premarket Approval Applications P91-2 Do
(blue book memo)
----------------------------------------------------------------------------------------------------------------
Premarket Approval Application Compliance Program P91-3 Do
(blue book memo)
----------------------------------------------------------------------------------------------------------------
Shelf Life of Medical Devices Do
----------------------------------------------------------------------------------------------------------------
Device Labeling Guidance G91-1 (blue book memo) Do
----------------------------------------------------------------------------------------------------------------
Consolidated Review of Submissions for Diagnostic Ultrasound Do
Equipment, Accessories and Related Measurement Devices < greek-
i>G90-2 (blue book memo)
----------------------------------------------------------------------------------------------------------------
Consolidated Review of Submissions for Lasers and Accessories Do
G90-1 (blue book memo)
----------------------------------------------------------------------------------------------------------------
Assignment of Review Documents I90-2 (blue book memo) Do
----------------------------------------------------------------------------------------------------------------
Policy Development and Review Procedures I90-1 (blue book Do
memo)
----------------------------------------------------------------------------------------------------------------
Substantial Equivalence Decision Making Documentation ATTACHED: Do
`SE' Decision Making Process (Detailed) (i.e., the decision
making tree)
----------------------------------------------------------------------------------------------------------------
Threshold Assessment of the Impact of Requirements for Submission Do
of Premarket Approval Applications for 31 Medical Devices
Marketed Prior to May 28, 1976
----------------------------------------------------------------------------------------------------------------
Meetings With the Regulated Industry I89-3 (blue book Do
memo)
----------------------------------------------------------------------------------------------------------------
Toxicology Risk Assessment Committee G89-1 (blue book Do
memo)
----------------------------------------------------------------------------------------------------------------
Review of IDEs for Feasibility Studies D89-1 (blue book Do
memo)
----------------------------------------------------------------------------------------------------------------
Premarket Notification--Consistency of Reviews K89-1 Do
(blue book memo)
----------------------------------------------------------------------------------------------------------------
Review of Laser Submissions G88-1 (blue book memo) Do
----------------------------------------------------------------------------------------------------------------
Guideline on Validation of the Limulus Amebocyte Lysate Test as an Do
End-Product Endotoxin Test
----------------------------------------------------------------------------------------------------------------
Limulus Amebocute Lysate; Reduction of Samples for Testing M. Sussan Runer, Center for Devices and
Radiological Health (HFZ-480), Food and
Drug Administration, 9200 Corporate
Blvd., Rockville, MD 20850, 301-827-5283
----------------------------------------------------------------------------------------------------------------
Master Files Part III; Guidance on Scientific and Technical Do
Information
----------------------------------------------------------------------------------------------------------------
Guideline on General Principles of Process Validation Do
----------------------------------------------------------------------------------------------------------------
Industry Representatives on Scientific Panel Do
----------------------------------------------------------------------------------------------------------------
Guidance on the Center for Devices and Radiological Health's Do
Premarket Notification Review Program K86-3 (blue book
memo)
----------------------------------------------------------------------------------------------------------------
Panel Report and Recommendations on PMA Approvals P86-5 Do
(blue book memo)
----------------------------------------------------------------------------------------------------------------
Points to Consider in the Characterization of Cell Lines Used to Do
Produce Biological Products
----------------------------------------------------------------------------------------------------------------
Application of the Device Good Manufacturing Practice Regulation Do
to the Manufacture of Sterile Devices
----------------------------------------------------------------------------------------------------------------
Methods for Conducting Recall Effectiveness Checks Do
----------------------------------------------------------------------------------------------------------------
Guidance for Submitting Reclassification Petition Do
----------------------------------------------------------------------------------------------------------------
Guidance for Industry and FDA: User Fees and Refunds for Premarket Do
Approval Applications
----------------------------------------------------------------------------------------------------------------
Bundling Multiple Devices or Multiple Indications in a Single Do
Submission--Guidance for Industry and FDA Staff
----------------------------------------------------------------------------------------------------------------
[[Page 41519]]
FDA and Industry Actions on Premarket Approval Applications: Do
Effect on FDA Review Clock and Performance Assessment
----------------------------------------------------------------------------------------------------------------
Reprocessing and Reuse of Single-Use Devices: Review Do
Prioritization Scheme; Draft
----------------------------------------------------------------------------------------------------------------
Class II Special Controls Guidance Document: Apnea Monitors; Do
Guidance for Industry and FDA
----------------------------------------------------------------------------------------------------------------
Class II Special Controls Guidance Document: Cutaneous Carbon Do
Dioxide (PcCo2 and Oxygen (PcO2) Monitors; Guidance for Industry
and FDA
----------------------------------------------------------------------------------------------------------------
Class II Special Controls Guidance Document: Indwelling Blood Gas Do
Analyzers; Final Guidance for Industry and FDA
----------------------------------------------------------------------------------------------------------------
Heated Humidifier Review Guidance Do
----------------------------------------------------------------------------------------------------------------
Class II Special Controls Guidance Document: Optical Impression Anthony Watson, Center for Devices and
Systems for Computer Assisted Design and Manufacturing of Dental Radiological Health (HFZ-480), Food and
Restorations; Guidance for Industry and FDA Drug Administration, 9200 Corporate
Blvd., Rockville, MD 20850, 301-824-1287
----------------------------------------------------------------------------------------------------------------
Class II Special Controls Guidance Document: Intraoral Devices for Do
Snoring and/or Obstructive Sleep Apnea; Guidance for Industry and
FDA
----------------------------------------------------------------------------------------------------------------
Class II Special Controls Guidance Document: Dental Sonography and Do
Jaw Tracking Devices; Guidance for Industry and FDA Reviewers
----------------------------------------------------------------------------------------------------------------
Class II Special Controls Guidance Document: Root-Form Endosseous Do
Dental Implants and Abutments; Draft Guidance for Industry and
FDA
----------------------------------------------------------------------------------------------------------------
Overview of Information Necessary for Premarket Notification Do
Submissions for Endosseous Implants; Final
----------------------------------------------------------------------------------------------------------------
Guidance for the Preparation of Premarket Notifications for Dental Do
Composites
----------------------------------------------------------------------------------------------------------------
Dental Cements--Premarket Notification; Final Do
----------------------------------------------------------------------------------------------------------------
Dental Impression Materials--Premarket Notification; Final Do
----------------------------------------------------------------------------------------------------------------
Over-the-Counter Denture Cushions, Pads, Reliners, Repair Kits, Do
and Partially Fabricated Denture Kits; Final
----------------------------------------------------------------------------------------------------------------
Information Necessary for Premarket Notification Submissions for Kevin Mulry, Center for Devices and
Screw-Type Endosseous Implants Radiological Health (HFZ-480), Food and
Drug Administration, 9200 Corporate
Blvd., Rockville, MD 20850, 301-827-5283
----------------------------------------------------------------------------------------------------------------
Guidance Document on Dental Handpieces Do
----------------------------------------------------------------------------------------------------------------
Guidance for the Arrangement and Content of a Premarket Approval Do
Application for an Endosseous Implant for Prosthetic Attachment
----------------------------------------------------------------------------------------------------------------
Premarket Notification Submissions for Chemical Indicators; Do
Guidance for Industry and FDA Staff
----------------------------------------------------------------------------------------------------------------
Draft Guidance for Industry and FDA Staff; Class II Special Do
Controls Guidance Document: Dental Precious Metal Alloys
----------------------------------------------------------------------------------------------------------------
Draft Guidance for Industry and FDA Staff; Class II Special Do
Controls Guidance Document: Dental Base Metal Alloys
----------------------------------------------------------------------------------------------------------------
Supplementary Guidance on Premarket Notifications for Medical Do
Devices With Sharps Injury Prevention Features; Guidance for
Industry and FDA
----------------------------------------------------------------------------------------------------------------
Guidance on Premarket Notifications for Intravascular Do
Administration Sets
----------------------------------------------------------------------------------------------------------------
Neonatal and Neonatal Transport Incubators--Premarket Do
Notifications; Final
----------------------------------------------------------------------------------------------------------------
Guidance on the Content of Premarket Notification Submissions for Do
Protective Restraints
----------------------------------------------------------------------------------------------------------------
Guidance on Premarket Notification Submissions for Short-Term and Do
Long-Term Intravascular Catheters
----------------------------------------------------------------------------------------------------------------
[[Page 41520]]
Guidance on the Content of Premarket Notification Submissions for Do
Hypodermic Single Lumen Needles
----------------------------------------------------------------------------------------------------------------
Guidance on the Content of Premarket Notification Submissions for Do
Piston Syringes
----------------------------------------------------------------------------------------------------------------
Guidance on the Content of Premarket Notification Submissions for Do
Clinical Electronic Thermometers
----------------------------------------------------------------------------------------------------------------
Guidance on the Content of Premarket Notification Submissions for Do
External Infusion Pumps
----------------------------------------------------------------------------------------------------------------
Guidance on Premarket Notification Submissions for Implanted Do
Infusion Ports
----------------------------------------------------------------------------------------------------------------
Surgical Masks--Premarket Notification Submissions; Draft Guidance Bram D. Zuckerman, Center for Devices and
Radiological Health (HFZ-450), Food and
Drug Administration, 9200 Corporate
Blvd., Rockville, MD 20850, 301-443-8320
----------------------------------------------------------------------------------------------------------------
Regulatory Status of Disinfectants Used to Process Dialysate Do
Delivery Systems and Water Purification Systems for Hemodialysis;
Guidance for Industry and FDA
----------------------------------------------------------------------------------------------------------------
Premarket Notification Submissions for Medical Sterilization Do
Packaging Systems in Health Care Facilities; Draft Guidance for
Industry and FDA
----------------------------------------------------------------------------------------------------------------
Premarket Notifications for Biological Indicators Intended to Elias Mallis, Center for Devices and
Monitor Sterilizers Used in Health Care Facilities; Draft Radiological Health (HFZ-450), Food and
Guidance for Industry and FDA Reviewers Drug Administration, 9200 Corporate
Blvd., Rockville, MD 20850, 301-443-8517
----------------------------------------------------------------------------------------------------------------
Premarket Approval Applications for Sharps Needle Destruction Do
Devices; Final Guidance for Industry and FDA
----------------------------------------------------------------------------------------------------------------
Guidance on the Content and Format of Premarket Notification Do
Submissions for Liquid Chemical Sterilants and High Level
Disinfectants; Final
----------------------------------------------------------------------------------------------------------------
Premarket Notification Submissions for Testing for Skin Do
Sensitization to Chemicals in Natural Rubber Products; Final
----------------------------------------------------------------------------------------------------------------
Center for Devices and Radiological Health Regulatory Guidance for Do
Washers and Washer-Disinfectors Intended for Use in Processing
Reusable Medical Devices
----------------------------------------------------------------------------------------------------------------
Testing for Sensitizing Chemicals in Natural Rubber Latex Medical Do
Devices (Addendum to 944)
----------------------------------------------------------------------------------------------------------------
Addendum to: Guidance on Premarket Notification Submissions for Dina Fleisher, Center for Devices and
Sterilizers Intended for Use in Health Care Facilities Radiological Health (HFZ-450), Food and
Drug Administration, 9200 Corporate
Blvd., Rockville, MD 20850, 301-443-8517
----------------------------------------------------------------------------------------------------------------
Guidance on the Content and Format of Premarket Notification Do
Submissions for Sharps Containers
----------------------------------------------------------------------------------------------------------------
Guidance on Premarket Notification Submissions for Automated Do
Endoscope Washers, Washer/Disinfectors, and Disinfectors Intended
for Use in Health Care Facilities
----------------------------------------------------------------------------------------------------------------
Guidance on Premarket Notification Submissions for Surgical Gowns Do
and Surgical Drapes
----------------------------------------------------------------------------------------------------------------
Guidance on Premarket Notification for Sterilizers Intended for Ashley Boam, Center for Devices and
Use in Health Care Facilities Radiological Health (HFZ-450), Food and
Drug Administration, 9200 Corporate
Blvd., Rockville, MD 20850, 301-443-8243
----------------------------------------------------------------------------------------------------------------
Battery Guidance Megan Moynaham, Center for Devices and
Radiological Health (HFZ-450), Food and
Drug Administration, 9200 Corporate
Blvd., Rockville, MD 20850, 301-443-8517
----------------------------------------------------------------------------------------------------------------
Policy for Expiration Dating (DCRND RB92-G) Do
----------------------------------------------------------------------------------------------------------------
Balloon Valvuloplasty Guidance for the Submission of an A. Doyle Gantt, Center for Devices and
Investigational Device Exemption Application and a Premarket Radiological Health (HFZ-450), Food and
Approval Application Drug Administration, 9200 Corporate
Blvd., Rockville, MD 20850, 301-443-8262
----------------------------------------------------------------------------------------------------------------
[[Page 41521]]
Class II Special Controls Guidance Document: Arrhythmia Detector Do
and Alarm
----------------------------------------------------------------------------------------------------------------
Cardiac Ablation Catheters Generic Arrhythmia Indications for Use; Do
Guidance for Industry
----------------------------------------------------------------------------------------------------------------
Investigational Device Exemption Study Enrollment for Cardiac Do
Ablation of Typical Atrial Flutter; Final Guidance for Industry
and FDA Reviewers
----------------------------------------------------------------------------------------------------------------
Recommended Clinical Study Design for Ventricular Tachycardia Neil R. Ogden, Center for Devices and
Ablation Radiological Health (HFZ-410), Food and
Drug Administration, 9200 Corporate
Blvd., Rockville, MD 20850, 301-594-1307
----------------------------------------------------------------------------------------------------------------
Nonautomated Sphygmomanometer (Blood Pressure Cuff) Guidance Do
Version 1; Final
----------------------------------------------------------------------------------------------------------------
Noninvasive Blood Pressure Monitor Guidance Do
----------------------------------------------------------------------------------------------------------------
Electrocardiograph Electrode Do
----------------------------------------------------------------------------------------------------------------
Electrocardiograph Lead Switching Adapter Do
----------------------------------------------------------------------------------------------------------------
Electrocardiograph Surface Electrode Tester Do
----------------------------------------------------------------------------------------------------------------
Clinical Study Designs for Percutanwous Catheter Ablation for Do
Treatment of Atrial Fibrillation--Guidance for Industry and FDA
Staff
----------------------------------------------------------------------------------------------------------------
Guidance for Annuloplasty Rings Premarket Notification Barbara Zimmerman, Center for Devices and
Submissions; Final Guidance for Industry and FDA Staff Radiological Health (HFZ-410), Food and
Drug Administration, 9200 Corporate
Blvd., Rockville, MD 20850, 301-594-2036
----------------------------------------------------------------------------------------------------------------
Guidance for Cardiopulmonary Bypass Arterial Line Blood Filter Do
Premarket Notification Submissions; Final Guidance for Industry
and FDA
----------------------------------------------------------------------------------------------------------------
Guidance for Extracorporeal Blood Circuit Defoamer Premarket Do
Notification Submissions; Final Guidance for Industry and FDA
----------------------------------------------------------------------------------------------------------------
Guidance for Cardiopulmonary Bypass Oxygenators Premarket Do
Notification Submissions; Final Guidance for Industry and FDA
Staff
----------------------------------------------------------------------------------------------------------------
Guidance for the Preparation of the Annual Report to the Premarket Do
Approval Application Approved Heart Valve Prostheses
----------------------------------------------------------------------------------------------------------------
Coronary and Cerebrovascular Guidewire Guidance Do
----------------------------------------------------------------------------------------------------------------
Guidance for the Submission of Research and Marketing Applications Do
for Permanent Pacemaker Leads and for Pacemaker Lead Adaptor
Premarket Notification Submissions
----------------------------------------------------------------------------------------------------------------
Implantable Pacemaker Testing Guidance Do
----------------------------------------------------------------------------------------------------------------
Guidance Document for Vascular Prostheses Premarket Notification Do
Submissions
----------------------------------------------------------------------------------------------------------------
Guidance for Cardiovascular Intravascular Filter Premarket Do
Notification Submissions; Final
----------------------------------------------------------------------------------------------------------------
Carotid Stent--Suggestions for Content of Submissions to the Food Do
and Drug Administration in Support of Investigational Devices
Exemption Applications
----------------------------------------------------------------------------------------------------------------
Class II Special Controls Guidance Document: Vascular and Do
Neurovascular Embolization Devices--Draft Guidance for Industry
and FDA Staff
----------------------------------------------------------------------------------------------------------------
Guidance Document for Powered Suction Pump Premarket Notifications Steven Rhodes, Center for Devices and
Radiological Health (HFZ-410), Food and
Drug Administration 9200 Corporate Blvd.,
Rockville, MD 20850, 301-594-3090
----------------------------------------------------------------------------------------------------------------
Guidance Document for Surgical Lamp Premarket Notification; Final Do
----------------------------------------------------------------------------------------------------------------
Guidelines for Reviewing Premarket Notifications That Claim Do
Substantial Equivalence to Evoked Response Stimulators
----------------------------------------------------------------------------------------------------------------
Guidance Document for the Preparation of Premarket Notification Do
Applications for Electromyograph Needle Electrodes
----------------------------------------------------------------------------------------------------------------
[[Page 41522]]
Guidance on the Content and Organization of a Premarket Do
Notification for a Medical Laser
----------------------------------------------------------------------------------------------------------------
Guidance for the Preparation of a Premarket Notification for Do
Extended Laparoscopy Devices
----------------------------------------------------------------------------------------------------------------
Class II Special Controls Guidance Document: Knee Joint Do
Patellofemorotibial and Femorotibial Metal/Polymer Porous-Coated
Uncemented Prostheses; Guidance for Industry and FDA
----------------------------------------------------------------------------------------------------------------
Class II Special Controls Guidance Document: Do
Polymethylmethacrylate Bone Cement; Guidance for Industry and FDA
----------------------------------------------------------------------------------------------------------------
Class II Special Controls Guidance Document: Hip Joint Metal/ Theodore R. Stevens, Center for Devices
Polymer Constrained Cemented or Uncemented Prosthesis and Radiological Health (HFZ-410), Food
and Drug Administration, 9200 Corporate
Blvd., Rockville, MD 20850, 301-594-1296
----------------------------------------------------------------------------------------------------------------
Class II Special Controls Guidance: Shoulder Joint Metal/Polymer/ Do
Metal Nonconstrained or Semiconstrained Porous-Coated Uncemented
Prosthesis Guidance for Spinal System Premarket Notifications
----------------------------------------------------------------------------------------------------------------
Guidance Document for the Preparation of Investigational Device Do
Exemptions for Spinal Systems
----------------------------------------------------------------------------------------------------------------
ORDB Premarket Notification Sterility Review Guidance Do
----------------------------------------------------------------------------------------------------------------
Reviewers Guidance Checklist for Intramedullary Rods Do
----------------------------------------------------------------------------------------------------------------
Reviewers Guidance Checklist for Orthopedic External Fixation Do
Devices
----------------------------------------------------------------------------------------------------------------
Premarket Notification Information Needed for Hydroxyapatite Do
Coated Orthopedic Implants
----------------------------------------------------------------------------------------------------------------
Guidance Document for Testing Biodegradable Polymer Implant Do
Devices
----------------------------------------------------------------------------------------------------------------
Guidance Document for Testing Bone Anchor Devices Do
----------------------------------------------------------------------------------------------------------------
Guidance Document for Testing Non-Articulating, `Mechanically Do
Locked', Modular Implant Components
----------------------------------------------------------------------------------------------------------------
Guidance Document for the Preparation of Premarket Notification Do
for Ceramic Ball Hip Systems
----------------------------------------------------------------------------------------------------------------
Guidance Document for Testing Orthopedic Implants With Modified Do
Metallic Surfaces Apposing Bone or Bone Cement
----------------------------------------------------------------------------------------------------------------
Guidance Document for the Preparation of Investigational Device Do
Exemption and Premarket Approval Applications for Intra-Articular
Prosthetic Knee Ligament Devices
----------------------------------------------------------------------------------------------------------------
Class II Special Controls Guidance Document: Surgical Sutures; Evertte T. Bears, Center for Devices and
Guidance for Industry and FDA Radiological Health (HFZ-460), Food and
Drug Administration, 9200 Corporate
Blvd., Rockville, MD 20850, 301-594-2018
----------------------------------------------------------------------------------------------------------------
Guidance for Saline, Silicone Gel, and Alternative Breast Do
Implants; Guidance for Industry and FDA
----------------------------------------------------------------------------------------------------------------
Class II Special Controls Guidance Document: Human Dura Mater; Do
Guidance for Industry and FDA
----------------------------------------------------------------------------------------------------------------
Guidance for Resorbable Adhesion Barrier Devices for Use in Do
Abdominal and/or Pelvic Surgery; Guidance for Industry
----------------------------------------------------------------------------------------------------------------
Guidance Document for Dura Substitute Devices; Final Guidance for Do
Industry
----------------------------------------------------------------------------------------------------------------
Guidance for Neurological Embolization Devices Do
----------------------------------------------------------------------------------------------------------------
Guidance for the Preparation of a Premarket Notification Do
Application for Processed Human Dura Mater; Final
----------------------------------------------------------------------------------------------------------------
Guidance for Dermabrasion Devices; Final Do
----------------------------------------------------------------------------------------------------------------
[[Page 41523]]
Guidance for the Preparation of a Premarket Notification Do
Application for a Surgical Mesh; Final
----------------------------------------------------------------------------------------------------------------
Guidance for Content of Premarket Notifications for Esophageal and Eric A, Mann, Center for Devices and
Tracheal Prostheses; Final Radiological Health (HFZ-460), Food and
Drug Administration, 9200 Corporate
Blvd., Rockville, MD 20850, 301-594-2080
----------------------------------------------------------------------------------------------------------------
Guidance for Testing Magnetic Resonance Interaction With Aneurysm Do
Clips
----------------------------------------------------------------------------------------------------------------
Class II Special Controls Guidance Document: Resorbable Calcium Do
Salt Bone Void Filler Device; Guidance for Industry and FDA
----------------------------------------------------------------------------------------------------------------
Cyanoacrylate Tissue Adhesive for the Topical Approzimation of Do
Ski--Premarket Approval Applications--Guidance for Industry and
FDA Staff
----------------------------------------------------------------------------------------------------------------
Saline, Silicone Gel, and Alternative Breast Implants--Draft Kesia Alexander, Center for Devices and
Guidance for Industry Radiological Health (HFZ-460), Food and
Drug Administration, 9200 Corporate
Blvd., Rockville, MD 20850, 301-594-2053
----------------------------------------------------------------------------------------------------------------
Guidance Document for Powered Muscle Stimulator Premarket
Notifications; Final
----------------------------------------------------------------------------------------------------------------
Guidance Document for the Preparation of Premarket Notification Do
Applications for Therapeutic Massagers and Vibrators
----------------------------------------------------------------------------------------------------------------
Guidance Document for the Preparation of Premarket Notification Do
Applications for Beds
----------------------------------------------------------------------------------------------------------------
Guidance Document for the Preparation of Premarket Notification Do
Applications for Communications Systems (Powered and Nonpowered)
and Powered Environmental Control Systems
----------------------------------------------------------------------------------------------------------------
Guidance Document for the Preparation of Premarket Notification Do
Applications for Exercise Equipment
----------------------------------------------------------------------------------------------------------------
Guidance Document for the Preparation of Premarket Notification Do
Applications for Heating and Cooling Devices
----------------------------------------------------------------------------------------------------------------
Guidance Document for the Preparation of Premarket Notification Do
Applications for Immersion Hydrobaths
----------------------------------------------------------------------------------------------------------------
Guidance Document for the Preparation of Premarket Notification Carolyn Y. Neuland, Center for Devices and
Applications for Powered Tables and Multifunctional Physical Radiological Health (HFZ-470), Food and
Therapy Tables Drug Administration, 9200 Corporate
Blvd., Rockville, MD 20850, 301-594-1220
----------------------------------------------------------------------------------------------------------------
Guidance Document for the Preparation of Premarket Notification Do
Applications for Submerged (Underwater) Exercise Equipment
----------------------------------------------------------------------------------------------------------------
Guidance Document for the Preparation of Premarket Notification Do
Applications for Mechanical and Powered Wheelchairs, and
Motorized Three-Wheeled Vehicles
----------------------------------------------------------------------------------------------------------------
Guidance for Studies for Pain Therapy Devices--General Do
Consideration in the Design of Clinical Studies for Pain-
Alleviating Devices
----------------------------------------------------------------------------------------------------------------
Guidance Document for Nonprescription Sunglasses; Final Do
Ophthalmoscope Guidance
----------------------------------------------------------------------------------------------------------------
Retinoscope Guidance; Final Do
----------------------------------------------------------------------------------------------------------------
Slit Lamp Guidance; Final Do
----------------------------------------------------------------------------------------------------------------
Third Party Review Guidance for Phacofragmentation System Device Do
Premarket Notification
----------------------------------------------------------------------------------------------------------------
Third Party Review Guidance for Vitreous Aspiration and Cutting Collin M. Pollard, Center for Devices and
Device Premarket Notification Radiological Health (HFZ-470), Food and
Drug Administration, 9200 Corporate
Blvd., Rockville, MD 20850, 301-594-1180
----------------------------------------------------------------------------------------------------------------
Checklist of Information Usually Submitted in an Investigational Do
Device Exemptions Application for Refractive Surgery Lasers
(Excimer)
----------------------------------------------------------------------------------------------------------------
Implantable Middle Ear Hearing Device; Guidance for Industry and Do
FDA
----------------------------------------------------------------------------------------------------------------
[[Page 41524]]
Guidance for Manufacturers Seeking Marketing Clearance of Ear, Do
Nose, and Throat Endoscope Sheaths Used as Protective Barriers;
Final
----------------------------------------------------------------------------------------------------------------
Tympanostomy Tubes, Submission Guidance for a Premarket Do
Notification; Final
----------------------------------------------------------------------------------------------------------------
Guidance For The Arrangement and Content of a Premarket Approval Do
Application For A Cochlear Implant in Children Ages 2 to 17 Years
----------------------------------------------------------------------------------------------------------------
Guideline for the Arragement and Content of a Premarket Approval Do
Application for a Cochlear Implant in Adults at Least 18 Years of
Age
----------------------------------------------------------------------------------------------------------------
Guideline for the Arrangement and Content of a Premarket Approval Do
Application for a Cochlear Implant in Adults at Least 18 Years of
Age
----------------------------------------------------------------------------------------------------------------
Guidance on Submissions for Keratoprostheses; Final Do
----------------------------------------------------------------------------------------------------------------
Aqueous Shunts--Premarket Notification Submissions; Final Do
----------------------------------------------------------------------------------------------------------------
FDA Guidelines for Multifocal Intraocular Lens Investigational Do
Device Exemptions Studies and Premarket Approval Applications
----------------------------------------------------------------------------------------------------------------
Important Information About Rophae Intraocular Lenses Do
----------------------------------------------------------------------------------------------------------------
Guidance for Premarket Submissions of Orthokeratology Rigid Gas Do
Permeable Contact Lenses; Final
----------------------------------------------------------------------------------------------------------------
Revised Procedures for Adding Lens Finishing Laboratories to Do
Approved Premarket Approval Applications for Class III Rigid Gas
Permeable Contact Lenses for Extended Wear; Final
----------------------------------------------------------------------------------------------------------------
Premarket Notification Guidance for Contact Lens Care Products Do
----------------------------------------------------------------------------------------------------------------
Premarket Notification Guidance Document for Class II Daily Wear Do
Contact Lenses
----------------------------------------------------------------------------------------------------------------
New FDA Recommendations and Results of Contact Lens Study (7-Day Do
Letter)
----------------------------------------------------------------------------------------------------------------
Class II Special Controls Guidance Document; Ingestible Telemetric Do
Gastrointestinal Capsule Imaging System; Final Guidance for
Industry and FDA
----------------------------------------------------------------------------------------------------------------
Class II Special Controls Guidance Document: Tissue Culture Media Janine M. Morris, Center for Devices and
for Human Ex Vivo Tissue and Cell Culture Processing Radiological Health (HFZ-470), Food and
Applications; Final Guidance for Industry and FDA Reviewers Drug Administration, 9200 Corporate
Blvd., Rockville, MD 20850, 301-594-2194
----------------------------------------------------------------------------------------------------------------
Guidance for Investigational Device Exemptions for Solutions for Do
Hypothermic Flushing, Transport, and Storage of Organs for
Transplantation; Final Guidance for Industry and FDA Reviewers
----------------------------------------------------------------------------------------------------------------
Guidance for Industry and the Center for Devices and Radiological Do
Health Reviewers on the Content of Premarket Notifications for
Hemodialysis Delivery Systems; Final
----------------------------------------------------------------------------------------------------------------
Guidance for the Content of Premarket Notification for Do
Conventional and High Permeability Hemodialyzers; Final
----------------------------------------------------------------------------------------------------------------
Guidance for the Content of Premarket Notifications for Metal Do
Expandable Biliary Stents; Final
----------------------------------------------------------------------------------------------------------------
Guidance for the Content of Premarket Notifications for Water Do
Purification Components and Systems for Hemodialysis
----------------------------------------------------------------------------------------------------------------
Class II Special Controls Guidance Document: Breast Lesion Do
Documentation System--Guidance for Industry and FDA Staff
----------------------------------------------------------------------------------------------------------------
Class II Special Controls Guidance for Home Uterine Activity Do
Monitors; Final Guidance for Industry and FDA Reviewers
----------------------------------------------------------------------------------------------------------------
Class II Special Controls Guidance Document for Clitoral Do
Engorgement Devices
----------------------------------------------------------------------------------------------------------------
Latex Condoms for Men--Information for Premarket Notifications: Do
Use of Consensus Standards for Abbreviated Submissions
----------------------------------------------------------------------------------------------------------------
Uniform Contraceptive Labeling; Final Do
----------------------------------------------------------------------------------------------------------------
Letter to Manufacturers of Prescription Home Monitors for Non- Do
Stress Tests
----------------------------------------------------------------------------------------------------------------
[[Page 41525]]
Letter to Manufacturers of Falloposcopes Do
----------------------------------------------------------------------------------------------------------------
Thermal Endometrial Ablation Devices (Submission Guidance for an Do
Investigational Device Exemption)
----------------------------------------------------------------------------------------------------------------
Hysteroscopes and Gynecology Laparoscopes--Submission Guidance for Do
a Premarket Notification
----------------------------------------------------------------------------------------------------------------
Premarket Applications for Digital Mammography Systems; Final Do
Guidance for Industry and FDA
----------------------------------------------------------------------------------------------------------------
Guidance for the Submission of Premarket Notifications for Photon- Do
Emitting Brachytherapy Sources
----------------------------------------------------------------------------------------------------------------
Guidance for the Submission of Premarket Notifications for Medical Do
Image Management Devices
----------------------------------------------------------------------------------------------------------------
Guidance for the Submission of Premarket Notification for Solid Do
State X-Ray Imaging Devices; Final
----------------------------------------------------------------------------------------------------------------
Guidance for the Submission of Premarket Notifications for Do
Emission Computed Tomography Devices and Accessories and Nuclear
Tomography Systems; Final
----------------------------------------------------------------------------------------------------------------
Guidance for the Submission of Premarket Notifications for Do
Radionuclide Dose Calibrators; Final
----------------------------------------------------------------------------------------------------------------
Harmonic Imaging With/Without Contrast--Premarket Notification; Do
Final
----------------------------------------------------------------------------------------------------------------
Guidance for the Submission of Premarket Notifications for Do
Magnetic Resonance Diagnostic Devices; Final
----------------------------------------------------------------------------------------------------------------
Information for Manufacturers Seeking Marketing Clearance of Do
Diagnostic Ultrasound Systems and Transducers
----------------------------------------------------------------------------------------------------------------
Letter: Notice to Manufacturers of Bone Mineral Densitometers Do
----------------------------------------------------------------------------------------------------------------
Simplified Premarket Notification Procedures for Certain Radiology Avis T. Danishefsky, Center for Devices
Devices: December 21, 1993, Letter From L Yin, Office of Device and Radiological Health (HFZ-440), Food
Evaluation, Division of Reproduction, Abdominal, and Radiological and Drug Administration, 9200 Corporate
Devices, to National Electrical Manufacturers Association Blvd., Rockville, MD 20850, 301-594-1243
----------------------------------------------------------------------------------------------------------------
Reviewer Guidance for Automatic X-Ray Film Processor Premarket Do
Notification
----------------------------------------------------------------------------------------------------------------
Guidance for the Content of Premarket Notifications for Do
Extracorporeal Shock Wave Lithotripters Indicated for the
Fragmentation of Kidney and Ureteral Calculi
----------------------------------------------------------------------------------------------------------------
Guidance for the Content of Premarket Notifications for Penile Do
Rigidity Implants; Final
----------------------------------------------------------------------------------------------------------------
Guidance for the Content of Premarket Notifications for Do
Intracorporeal Lithotripters; Final
----------------------------------------------------------------------------------------------------------------
Center for Devices and Radiological Health Interim Regulatory Do
Policy for External Penile Rigidity Devices
----------------------------------------------------------------------------------------------------------------
Checklist for Mechanical Lithotripters and Stone Dislodgers Used Do
in Gastroenterology and Urology
----------------------------------------------------------------------------------------------------------------
Premarket Notification Checklist for Sterile Lubricating Jelly Do
Used With Transurethral Surgical Instruments
----------------------------------------------------------------------------------------------------------------
Guidance for the Content of Premarket Notifications for Do
Conventional and Antimicrobial Foley Catheters
----------------------------------------------------------------------------------------------------------------
Guidance for the Content of Premarket Notifications for Urodynamic/ Do
Uroflowmetry Systems
----------------------------------------------------------------------------------------------------------------
Guidance for the Content of Premarket Notifications for Urine Do
Drainage Bags
----------------------------------------------------------------------------------------------------------------
Guidance for the Content of Premarket Notifications for Biopsy Do
Devices Used in Gastroenterology and Urology
----------------------------------------------------------------------------------------------------------------
Guidance for the Content of Premarket Notifications for Ureteral Do
Stents
----------------------------------------------------------------------------------------------------------------
Perspectives on Clinical Studies for Medical Device Submissions Do
(Statistical)
----------------------------------------------------------------------------------------------------------------
[[Page 41526]]
Premarket Approval Application Review Statistical Checklist Do
----------------------------------------------------------------------------------------------------------------
Statistical Guidance for Clinical Trials of Nondiagnostic Medical Do
Devices
----------------------------------------------------------------------------------------------------------------
Medical Device Reporting Guidance Document: Remedial Action Do
Exemption; Final
----------------------------------------------------------------------------------------------------------------
Guidance on Adverse Event Reporting for Hospitals That Reprocess Do
Devices Intended by the Original Equipment Manufacturer for
Single Use
----------------------------------------------------------------------------------------------------------------
Medical Device Reporting Guidance Document No. 1--Intraocular Do
lenses--E1996004; Final
----------------------------------------------------------------------------------------------------------------
Common Problems: Baseline Reports and Medwatch Form 3500A Do
----------------------------------------------------------------------------------------------------------------
Medical Device Reporting: An Overview; Final Do
----------------------------------------------------------------------------------------------------------------
Instructions for Completing FDA Form 3500A With Coding Manual for Do
Form 3500A (MEDWATCH) (Medical Device Reporting); Final
----------------------------------------------------------------------------------------------------------------
MEDWATCH FDA Form 3500A For Use By User Facilities, Distributors Do
and Manufacturers for Mandatory Reporting (Medical Device
Reporting); Final
----------------------------------------------------------------------------------------------------------------
Variance from Manufacturer Report Number Format (Medical Device Do
Reporting Letter); Final
----------------------------------------------------------------------------------------------------------------
Instructions for Completing Form 3417: Medical Device Reporting Do
Baseline Report (Medical Device Reporting); Final
----------------------------------------------------------------------------------------------------------------
Medical Device Reporting--Alternative Summary Reporting Program; Do
Guidance for Industry
----------------------------------------------------------------------------------------------------------------
Addendum to the Instructions for Completing FDA Form 3500A With Do
Coding Manual (MEDWATCH) (Medical Device Reporting); Final
----------------------------------------------------------------------------------------------------------------
Needlesticks--Medical Device Reporting Guidance Do
----------------------------------------------------------------------------------------------------------------
Guidance on Criteria and Approaches for Postmarket Surveillance Do
----------------------------------------------------------------------------------------------------------------
Guidance on Procedures to Determine Application of Postmarket Do
Surveillance Strategies (Food and Drug Administration
Modernization Act); Final
----------------------------------------------------------------------------------------------------------------
Guidance on Procedures for Review of Postmarket Surveillance Do
Submissions (Food and Drug Administration Modernization Act);
Final
----------------------------------------------------------------------------------------------------------------
Guidance for Industry and FDA Staff--Safe Medical Devices Act to Do
Food and Drug Administration Modernization Act: Guidance on FDA's
Transition Plan for Existing Postmarket Surveillance Protocols
(Food and Drug Administration Modernization Act); Final
----------------------------------------------------------------------------------------------------------------
Guidance for Industry on the Testing of Metallic Plasma Sprayed Do
Coatings on Orthopedic Implants to Support Reconsideration of
Postmarket
================================================================================================================
Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)
================================================================================================================
Analyte Specific Reagents; Small Entity Compliance Guidance; Do
Guidance for Industry
----------------------------------------------------------------------------------------------------------------
Assessing the Safety/Effectiveness of Home-Use In Vitro Diagnostic Do
Devices: Draft Points to Consider Regarding Labeling and
Premarket Submissions
----------------------------------------------------------------------------------------------------------------
Data for Commercialization of Original Equipment Manufacturer, Do
Secondary and Generic Reagents for Automated Analyzers
----------------------------------------------------------------------------------------------------------------
Determination of Intended Use for Premarket Notification Devices; Do
Guidance for the Center for Devices and Radiological Health Staff
----------------------------------------------------------------------------------------------------------------
Guidance for Administrative Procedures for Clinical Laboratory Do
Improvement Amendments of 1988 Categorization
----------------------------------------------------------------------------------------------------------------
Guidance for Clinical Laboratory Improvement Amendments of 1988 Do
Criteria for Waiver; Draft Guidance for Industry and FDA
----------------------------------------------------------------------------------------------------------------
Guidance for Industry--Abbreviated Premarket Notification Do
Submissions for In Vitro Diagnostic Calibrators; Final
----------------------------------------------------------------------------------------------------------------
[[Page 41527]]
Letter to In-Vitro Device Manufacturers on Streamlined Premarket Do
Approval Applications; Final
----------------------------------------------------------------------------------------------------------------
Points to Consider for Collection of Data in Support of In-Vitro Do
Device Submissions for Premarket Notification Clearance
----------------------------------------------------------------------------------------------------------------
Points to Consider for Review of Calibration and Quality Control Do
Labeling for In Vitro Diagnostic Devices/Cover Letter Dated March
14, 1996
----------------------------------------------------------------------------------------------------------------
Points to Consider Guidance Document on Assayed and Unassayed Do
Quality Control Material; Draft
----------------------------------------------------------------------------------------------------------------
Premarket Approval Application Filing Review--Guidance for Do
Industry and FDA Staff
----------------------------------------------------------------------------------------------------------------
Breath Nitric Oxide Test System--Class II Special Controls Do
Guidance Document
----------------------------------------------------------------------------------------------------------------
Class II Special Control Guidance Document for B-Type Natriuretic Do
Peptide Premarket Notifications; Final Guidance for Industry and
FDA Reviewers
----------------------------------------------------------------------------------------------------------------
Class II Special Controls Guidance Document: Cyclosporine and Do
Tacrolimus Assays; Guidance for Industry and FDA
----------------------------------------------------------------------------------------------------------------
Draft Guidance for Prescription Use of Drugs of Abuse Assays Do
Premarket Notifications
----------------------------------------------------------------------------------------------------------------
Draft Guidance on the Labeling for Over-the-Counter Sample Do
Collection Systems for Drugs of Abuse Testing
----------------------------------------------------------------------------------------------------------------
Guidance for Premarket Notifications on Cholesterol Tests for Do
Clinical Laboratory, Physicians' Office Laboratory, and Home Use
----------------------------------------------------------------------------------------------------------------
Guidance for Industry In Vitro Diagnostic Bicarbonate/Carbon Do
Dioxide Test System; Final
----------------------------------------------------------------------------------------------------------------
Guidance for Industry In Vitro Diagnostic Chloride Test System; Do
Final
----------------------------------------------------------------------------------------------------------------
Guidance for Industry In Vitro Diagnostic Creatinine Test System; Do
Final
----------------------------------------------------------------------------------------------------------------
Guidance for Industry In Vitro Diagnostic Glucose Test System; Do
Final
----------------------------------------------------------------------------------------------------------------
Guidance for Industry In Vitro Diagnostic Potassium Test System; Do
Final
----------------------------------------------------------------------------------------------------------------
Guidance for Industry In Vitro Diagnostic Sodium Test System; Do
Final
----------------------------------------------------------------------------------------------------------------
Guidance for Industry In Vitro Diagnostic Urea Nitrogen Test Do
System; Final
----------------------------------------------------------------------------------------------------------------
Guidance for Industry-In Vitro Diagnostic C-Reactive Protein Do
Immunological Test System
----------------------------------------------------------------------------------------------------------------
Guidance for Over-the-Counter Human Chorionic Gonadotropin Do
Premarket Notifications
----------------------------------------------------------------------------------------------------------------
Guidance for Over-the-Counter Ovulation Predictor Premarket Do
Notifications
----------------------------------------------------------------------------------------------------------------
Over the Counter Screening Tests for Drugs of Abuse: Guidance for Do
Premarket Notifications
----------------------------------------------------------------------------------------------------------------
Points to Consider for Portable Blood Glucose Monitoring Devices Do
Intended for Bedside Use in the Neonate Nursery
----------------------------------------------------------------------------------------------------------------
Review Criteria for Assessment of In Vitro Diagnostic Devices for Do
Drugs of Abuse Assays Using Various Methodologies
----------------------------------------------------------------------------------------------------------------
Review Criteria for Assessment of Portable Blood Glucose In Vitro Do
Diagnostic Devices Using Glucose Oxidase, Dehydrogenase, or
Hexokinase Methodology
----------------------------------------------------------------------------------------------------------------
Review Criteria for Assessment of Professional Use Human Chorionic Laura A. Alonge, Center for Devices and
Gonadotropin In Vitro Diagnostic Devices Radiological Health (HFZ-510), Food and
Drug Administration, 9200 Corporate
Blvd., Rockville, MD 20850, 301-594-0648
----------------------------------------------------------------------------------------------------------------
Premarket Notification Submissions for Coagulation Instruments-- Do
Guidance for Industry and FDA Staff
----------------------------------------------------------------------------------------------------------------
Class II Special Control Guidance Document for Anti-Saccharomyces Do
Cerevisia (S. cerevisiae) Antibody Premarket Notifications
----------------------------------------------------------------------------------------------------------------
[[Page 41528]]
Class II Special Controls Guidance Document: Premarket Do
Notifications for Automated Differential Cell Counters for
Immature or Abnormal Blood Cells; Final Guidance for Industry and
FDA
----------------------------------------------------------------------------------------------------------------
Document for Special Controls for Erythropoietin Assay Premarket Do
Notifications; Final
----------------------------------------------------------------------------------------------------------------
Draft Guidance Document for Premarket Notification Submission of Do
Fecal Occult Blood Tests
----------------------------------------------------------------------------------------------------------------
Draft Guidance Document for Premarket Notification Submission of Do
Glycohemoglobin (Glycated or Glycosylated) Hemoglobin for In
Vitro Diagnostic Devices
----------------------------------------------------------------------------------------------------------------
Draft Guidance Document for Premarket Notification Submission of Do
Immunoglobulins A,G,M,D and E Immunoglobulin System In-Vitro
Devices
----------------------------------------------------------------------------------------------------------------
Draft Guidance for Premarket Notification Submission of Lymphocyte Do
Immunophenotyping In Vitro Diagnostic Devices Using Monoclonal
Antibodies
----------------------------------------------------------------------------------------------------------------
Draft Guidance for Premarketing Approval Review Criteria for Do
Premarket Approval of Estrogen or Progesterone Receptors In Vitro
Diagnostic Devices Using Steroid Hormone Binding With Dextran-
Coated Charcoal Separation, Histochemical Receptor Bind
----------------------------------------------------------------------------------------------------------------
Guidance Document for the Submission of Tumor Associated Antigen Do
Premarket Notification to FDA
----------------------------------------------------------------------------------------------------------------
Guidance for Submission of Immunohistochemistry Applications to Do
FDA; Final
----------------------------------------------------------------------------------------------------------------
In Vitro Diagnostic Fibrin Monomer Paracoagulation Test; Final Do
----------------------------------------------------------------------------------------------------------------
Multiplex Tests for Heritable Deoxyribonucleic Acid Markers, Do
Mutations and Expression Patterns; Draft Guidance for Industry
and FDA Reviewers
----------------------------------------------------------------------------------------------------------------
Points to Consider for Cervical Cytology Devices Do
----------------------------------------------------------------------------------------------------------------
Points to Consider for Hematology Quality Control Materials Do
----------------------------------------------------------------------------------------------------------------
Radioallergosorbent Test Methods for Allergen-Specific Do
Immunoglobulin E (IgE) Premarket Notifications; Final Guidance
for Industry and FDA
----------------------------------------------------------------------------------------------------------------
Review Criteria for Assessment of Alpha-Fetoprotein In Vitro Do
Diagnostic Devices for Fetal Open Neural Tube Defects Using
Immunological Test Methodologies
----------------------------------------------------------------------------------------------------------------
Review Criteria for Assessment of Cytogenetic Analysis Using Do
Automated and Semiautomated Chromosome Analyzers
----------------------------------------------------------------------------------------------------------------
Review Criteria for Assessment of Rheumatoid Factor In Vitro Casper E. Uldriks, Center for Devices and
Diagnostic Devices Using Engzyme-Linked Immunoassay, Enzyme Radiological Health (HFZ-300), Food and
Linked Immunosorbent Assay, Particle Agglutination Tests, and Drug Administration, 9200 Corporate
Laser and Rate Nephelometry Blvd., Rockville, MD 20850, 301-594-4692
----------------------------------------------------------------------------------------------------------------
Review Criteria for Blood Culture Systems Do
----------------------------------------------------------------------------------------------------------------
Review Criteria for In Vitro Diagnostic Devices for Detection of Do
Immunoglobulin Class M Antibodies to Viral Agents
----------------------------------------------------------------------------------------------------------------
Review Criteria for In Vitro Diagnostic Devices for the Assessment Do
of Thyroid Autoantibodies Using Indirect Immunofluorescence
Assay, Indirect Hemagglutination Assay, Radioimmunoasay, and
Enzyme Linked Immunosorbent Assay
----------------------------------------------------------------------------------------------------------------
Review Criteria for In Vitro Diagnostic Devices that Utilize Do
Cytogenetic In Situ Hybridization Technology for the Detection of
Human Genetic Mutations (Germ Line and Somatic)
----------------------------------------------------------------------------------------------------------------
Review Criteria for the Assessment of Anti-Nuclear Antibodies In- Do
Vitro Diagnostic Devices Using Class II Special Controls Guidance
Document: Antimicrobial Susceptibility Test Systems; Guidance for
Industry and FDA
----------------------------------------------------------------------------------------------------------------
Draft Review Criteria for Nucleic Acid Amplification Based In Do
Vitro Diagnostic Devices for Direct Detection of Infectious
Microorganisms
----------------------------------------------------------------------------------------------------------------
Premarket Approval Applications for In Vitro Diagnostic Devices Do
Pertaining to Hepatitis C Viruses
----------------------------------------------------------------------------------------------------------------
[[Page 41529]]
Assays Intended for Diagnosis, Prognosis, or Monitoring of Do
Hepatitis C Virus Infection, Hepatitis C, or Other Hepatitis C-
Associated Disease; Draft Guidance for Industry FDA
----------------------------------------------------------------------------------------------------------------
Review Criteria for Assessment of Antimicrobial Susceptibility Do
Test Discs
----------------------------------------------------------------------------------------------------------------
Review Criteria for Assessment of In Vitro Diagnostic Devices for Do
Direct Detection of Chlamydiae in Clinical Specimens
----------------------------------------------------------------------------------------------------------------
Review Criteria for Assessment of In Vitro Diagnostic Devices for Do
Direct Detection of Mycobacterium spp. (Tuberculosis)
----------------------------------------------------------------------------------------------------------------
Review Criteria for Assessment of Laboratory Tests for the Do
Detection of Antibodies to Helicobacter Pylori
----------------------------------------------------------------------------------------------------------------
Review Criteria for Devices Assisting in the Diagnosis of Do
Clostriduim Difficile Associated Diseases
----------------------------------------------------------------------------------------------------------------
Review Criteria for Devices Intended for the Detection of Do
Hepatitis B `e' Antigen and Antibody to Hepatitis B `e'
----------------------------------------------------------------------------------------------------------------
Review Criteria For Premarket Approval of In Vitro Diagnostic Do
Devices for Detection of Antibodies to Parvovirus B19
================================================================================================================
Office of Surveillance and Biometrics
================================================================================================================
Perspectives on Clinical Studies for Medical Device Submissions Do
(Statistical)
----------------------------------------------------------------------------------------------------------------
Premarket Approval Application Review Statistical Checklist Do
----------------------------------------------------------------------------------------------------------------
Statistical Aspects of Submissions to FDA: A Medical Device Do
Perspective (Also Includes as Appendix the Article ``Observed
Uses and Abuses of Statistical Procedures in Medical Device
Submissions'')
----------------------------------------------------------------------------------------------------------------
Statistical Guidance for Clinical Trials of Nondiagnostic Medical Do
Devices
----------------------------------------------------------------------------------------------------------------
Statistical Guidance on Reporting Results From Studies Evaluating Do
Diagnostic Tests; Draft
----------------------------------------------------------------------------------------------------------------
Medical Device Reporting Guidance Document: Remedial Action Do
Exemption; Final
----------------------------------------------------------------------------------------------------------------
Guidance on Adverse Event Reporting for Hospitals That Reprocess Do
Devices Intended by the Original Equipment Manufacturer for
Single Use
----------------------------------------------------------------------------------------------------------------
Medical Device Reporting Guidance Document No. 1--Intraocular Do
Lenses--E1996004; Final
----------------------------------------------------------------------------------------------------------------
Common Problems: Baseline Reports and Medwatch Form 3500A Do
----------------------------------------------------------------------------------------------------------------
Medical Device Reporting: An Overview; Final Do
----------------------------------------------------------------------------------------------------------------
Instructions for Completing FDA Form 3500A With Coding Manual for Do
Form 3500A (MEDWATCH) (Medical Device Reporting); Final
----------------------------------------------------------------------------------------------------------------
MEDWATCH FDA Form 3500A For Use By User Facilities, Distributors Do
and Manufacturers for Mandatory Reporting; Final
----------------------------------------------------------------------------------------------------------------
Variance From Manufacturer Report Number Format (Medical Device Do
Reporting Letter); Final
----------------------------------------------------------------------------------------------------------------
Instructions for Completing Form 3417: Medical Device Reporting Do
Baseline Report (Medical Device Reporting); Final
----------------------------------------------------------------------------------------------------------------
Medical Device Reporting--Alternative Summary Reporting Program; Do
Guidance for Industry
----------------------------------------------------------------------------------------------------------------
Addendum to the Instructions for Completing FDA Form 3500A With Do
Coding Manual (MEDWATCH) (Medical Device Reporting); Final
----------------------------------------------------------------------------------------------------------------
Needlesticks--Medical Device Reporting Guidance Do
----------------------------------------------------------------------------------------------------------------
Guidance to Sponsors on the Development of a Discretionary Do
Postmarket Surveillance Study for Permanent Implantable Cardiac
Pacemaker Electrodes (Leads)
----------------------------------------------------------------------------------------------------------------
[[Page 41530]]
Guidance on Criteria and Approaches for Postmarket Surveillance Do
----------------------------------------------------------------------------------------------------------------
Guidance on Procedures to Determine Application of Postmarket Do
Surveillance Strategies (Food and Drug Administration
Modernization Act); Final
----------------------------------------------------------------------------------------------------------------
Guidance on Procedures for Review of Postmarket Surveillance Do
Submissions (Food and Drug Administration Modernization Act);
Final
----------------------------------------------------------------------------------------------------------------
Guidance for Industry and FDA Staff-- Safe Medical Devices Act of Do
1990 to Food and Drug Administration Modernization Act: Guidance
on FDA's Transition Plan for Existing Postmarket Surveillance
Protocols (Food and Drug Administration Modernization Act); Final
----------------------------------------------------------------------------------------------------------------
Amendment to Guidance on Discretionary Postmarket Surveillance on Do
Pacemaker Leads; Final
----------------------------------------------------------------------------------------------------------------
Guidance for Industry on the Testing of Metallic Plasma Sprayed Do
Coatings on Orthopedic Implants to Support Reconsideration of
Postmarket
================================================================================================================
Office of Compliance
================================================================================================================
Perspectives on Clinical Studies for Medical Device Submissions Do
(Statistical)
----------------------------------------------------------------------------------------------------------------
Commercial Distribution/Exhibit Letter Do
----------------------------------------------------------------------------------------------------------------
FDA Guide for Validation of Biological Indicator Incubation Time Do
----------------------------------------------------------------------------------------------------------------
Guide for Establishing and Maintaining a Calibration Constancy Do
Intercomparison System for Microwave Oven Compliance Survey
Instruments (FDA 88-8264)
----------------------------------------------------------------------------------------------------------------
General Principles of Software Validation; Draft Guidance Do
----------------------------------------------------------------------------------------------------------------
Guidance on Medical Device Tracking (Food and Drug Administration Do
Modernization Act); Guidance for Industry and FDA Staff
----------------------------------------------------------------------------------------------------------------
Compliance Program Guidance Manual: Inspection of Medical Devices; Do
Draft
----------------------------------------------------------------------------------------------------------------
Procedures for Laboratory Compliance Testing of Television Do
Revivers--Part of Television Packet
----------------------------------------------------------------------------------------------------------------
Guidance on Quality System Regulation Information for Various Do
Premarket Submissions; Draft
----------------------------------------------------------------------------------------------------------------
Surveillance and Detention without Physical Examination of Do
Surgeons' and/or Patient Examination Gloves; Guidance for
Industry
----------------------------------------------------------------------------------------------------------------
Manufacturers/Assemblers of Diagnostic X-Ray Systems: Enforcement Do
Policy for Positive-Beam Limitation Requirements in 21 CFR
1020.31 g)
----------------------------------------------------------------------------------------------------------------
Guidance for the Submission of Initial Reports on Diagnostic X-Ray Do
Systems and Their Major Components
----------------------------------------------------------------------------------------------------------------
Exemption From Reporting and Recordkeeping Requirements for Do
Certain Sunlamp Product Manufacturers
----------------------------------------------------------------------------------------------------------------
Letter to Medical Device Industry on Endoscopy and Laparoscopy Do
Accessories (Galdi)
----------------------------------------------------------------------------------------------------------------
Clarification of Radiation Control Regulations for Diagnostic X- Do
Ray Equipment (FDA 89-8221)
----------------------------------------------------------------------------------------------------------------
Compliance Policy Guide 7133.19: Retention of Microwave Oven Test Do
Record/Cover Letter: August 24, 1981, Retention of Records
Required by 21 CFR Part 1002
----------------------------------------------------------------------------------------------------------------
Guidance for the Submission of Abbreviated Radiation Safety Do
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 Abbreviated Radiation Safety Do
Report on X-Ray Tables, Cradles, Film Changers or Cassette
Holders Intended for Diagnostic Use
----------------------------------------------------------------------------------------------------------------
A Guide for the Submission of Abbreviated Radiation Safety Reports Do
on Image Receptor Support Devices for Mammography X-Ray Systems
----------------------------------------------------------------------------------------------------------------
[[Page 41531]]
Compliance Program Guidance Manual: Field Compliance Testing of Do
Diagnostic (Medical) X-Ray Equipment; Guidance for FDA Staff
----------------------------------------------------------------------------------------------------------------
Information Disclosure by Manufacturers to Assemblers for Do
Diagnostic X-Ray Systems; Final Guidance for Industry and FDA
----------------------------------------------------------------------------------------------------------------
Guide for Submission of Information on Accelerators Intended to Do
Emit X-Radiation Required Under 21 CFR 1002.10
----------------------------------------------------------------------------------------------------------------
Abbreviated Report on Radiation Safety for Microwave Products Do
(Other Than Microwave Ovens) (e.g., Microwave Heating, Microwave
Diathermy, Rheumatoid Factor Sealers, Induction, Dielectric
Heaters, Security Systems)
----------------------------------------------------------------------------------------------------------------
Guide for Preparing Reports on Radiation Safety of Microwave Ovens Do
----------------------------------------------------------------------------------------------------------------
Guide for Filing Annual Reports for X-Ray Components and Systems Do
----------------------------------------------------------------------------------------------------------------
Reporting and Compliance Guide for Television Products Including Do
Product Report, Supplemental Report, Radiation Safety Abbreviated
Report, Annual Report, Information and Guidance
----------------------------------------------------------------------------------------------------------------
Revised Guide for Preparing Annual Reports on Radiation Safety Do
Testing of Laser and Laser Light Show Products (Replaces FDA 82-
8127)
----------------------------------------------------------------------------------------------------------------
Guide for Preparing Abbreviated Reports of Microwave and Howard W. Cyr, Center for Devices and
Rheumatoid Factor-Emitting Electronic Products Intended for Radiological Health (HFZ-114), Food and
Medical Use Drug Administration, 9200 Corporate
Blvd., Rockville, MD 20850, 301-796-0297
----------------------------------------------------------------------------------------------------------------
Letter to Manufacturers and Importers of Microwave Ovens: Do
Information Requirements for Cookbooks and User and Service
Manuals
----------------------------------------------------------------------------------------------------------------
Abbreviated Report on Radiation Safety of Non-Medical Ultrasonic Do
Products
----------------------------------------------------------------------------------------------------------------
Guide for Preparing Product Reports for Medical Ultrasound Do
Products
----------------------------------------------------------------------------------------------------------------
Letter to Manufacturers, Distributors and Importers of Condom Do
Products
----------------------------------------------------------------------------------------------------------------
Letter to Manufacturers, Importers, and Repackagers of Condoms for Do
Contraception or Sexually-Transmitted Disease Prevention (Holt)
----------------------------------------------------------------------------------------------------------------
Letter to Condom Manufacturers and Distributors Do
----------------------------------------------------------------------------------------------------------------
Letter to Manufacturers/Repackers Using Cotton Do
----------------------------------------------------------------------------------------------------------------
Guide for Preparing Product Reports for Lasers and Products Do
Containing Lasers
----------------------------------------------------------------------------------------------------------------
Compliance Guide for Laser Products (FDA 86-8260) Do
----------------------------------------------------------------------------------------------------------------
Condoms: Inspection and Sampling at Domestic Manufacturers and of Do
All Repackers; Sampling From All Importers (Damaska Memo to Field
on April 8, 1987)
----------------------------------------------------------------------------------------------------------------
Dental Hand Piece Sterilization (Dear Doctor Letter) Do
----------------------------------------------------------------------------------------------------------------
Latex Labeling Letter (Johnson) Do
----------------------------------------------------------------------------------------------------------------
Pesticide Regulation Notice 94-4:Interim Measures for the Do
Registration of Antimicrobial Products/Liquid Chemical Germicides
With Medical Device Use Claims Under the Memorandum of
Understanding Between the Environmental Protection Agency and the
Food and Drug Administration
----------------------------------------------------------------------------------------------------------------
Guide for Preparing Product Reports for Lasers and Products ..........................................
Containing Lasers
----------------------------------------------------------------------------------------------------------------
Letter to Industry, Powered Wheelchair Manufacturers From RM Do
Johnson
----------------------------------------------------------------------------------------------------------------
Hazards of Volume Ventilators and Heated Humidifiers Do
----------------------------------------------------------------------------------------------------------------
Manufacturers and Initial Distributors of Sharps Containers and Do
Destroyers Used by Health Care Professionals
----------------------------------------------------------------------------------------------------------------
Ethylene Oxide; Ethylene Chlorohydrin; and EthyleneGlycol: Do
Proposed Maximum Residue Limits and Maximum Levels of Exposure
----------------------------------------------------------------------------------------------------------------
Letter to: Manufacturers and Users of Lasers for Refractive Do
Surgery (Excimer)
----------------------------------------------------------------------------------------------------------------
[[Page 41532]]
Shielded Trocars and Needles Used for Abdominal Access During Do
Laparoscopy Surveillance and Detention Without Physical
Examination of Condoms; Guidance for Industry; Draft
----------------------------------------------------------------------------------------------------------------
All U.S. Condom Manufacturers, Importers and Repackagers Do
----------------------------------------------------------------------------------------------------------------
Manufacturers and Initial Distributors of Hemodialyzers Do
----------------------------------------------------------------------------------------------------------------
Laser Light Show Safety--Who's Responsible? (FDA 86-8262) Do
----------------------------------------------------------------------------------------------------------------
Suggested State Regulations for Control of Radiation--Volume II Do
Nonionizing Radiation--Lasers (FDA Publication No. 83-8220)
----------------------------------------------------------------------------------------------------------------
Letter to All Foreign Manufacturers and Importers of Electronic Do
Products for Which Applicable FDA Performance Standards Exist
----------------------------------------------------------------------------------------------------------------
Guide for Submission of Information on Industrial X-Ray Equipment Do
Required Under 21 CFR 1002.10
----------------------------------------------------------------------------------------------------------------
Guidance for the Submission of Cabinet X-Ray System Reports Under Do
21 CFR 1020.40
----------------------------------------------------------------------------------------------------------------
Guide for Preparing Annual Reports on Radiation Safety Testing of Do
Electronic Products (General)
----------------------------------------------------------------------------------------------------------------
Computerized Devices/Processes Guidance--Application of the Do
Medical Device Good Manufacturing Practice to Computerized
Devices and Manufacturing Processes
----------------------------------------------------------------------------------------------------------------
Guide for Preparing Product Reports for Ultrasonic Therapy Do
Products (Physical Therapy Only)
----------------------------------------------------------------------------------------------------------------
Guide for Submission of Information on Industrial Radiofrequency Do
Dielectric Heater and Sealer Equipment Unter 21 CFR 1002.10 and
1002.12 (FDA 81-8137)
----------------------------------------------------------------------------------------------------------------
Guide for Preparing Annual Reports for Ultrasonic Therapy Products Do
----------------------------------------------------------------------------------------------------------------
Guide for Preparing Annual Reports on Radiation Safety Testing of Do
Sunlamps and Sunlamp Products (Replaces FDA 82-8127)
----------------------------------------------------------------------------------------------------------------
Guide for Preparing Annual Reports on Radiation Safety Testing of Do
Mercury Vapor (Replaces FDA 82-8127) Quality Control Guide for
Sunlamp Products (FDA 88-8234)
----------------------------------------------------------------------------------------------------------------
Guide for the Submission of Initial Reports on Computed Tomography Do
X-Ray Systems
----------------------------------------------------------------------------------------------------------------
Guide for Preparing Product Reports on Sunlamps and Sunlamp Do
Products (21 CFR Part 1002)
----------------------------------------------------------------------------------------------------------------
Letter: Policy on Maximum Timer Interval and Exposure Schedule for Do
Sunlamp Products
----------------------------------------------------------------------------------------------------------------
Reporting Guide for Product Reports on High Intensity Mercury Do
Vapor Discharge Lamps (21 CFR Part 1002)
----------------------------------------------------------------------------------------------------------------
Quality Control Practices for Compliance With the Federal Mercury Do
Vapor Lamp Performance Standard
----------------------------------------------------------------------------------------------------------------
Keeping Up With the Microwave Revolution (FDA Publication No. 91- Do
4160)
----------------------------------------------------------------------------------------------------------------
Quality Assurance Guidelines for Hemodialysis Devices Do
----------------------------------------------------------------------------------------------------------------
Letter to Manufacturers and Importers of Microwave Ovens--Open Do
Door Operation of Microwave Ovens as a Result of Oven Miswiring
----------------------------------------------------------------------------------------------------------------
Reporting of New Model Numbers to Existing Model Families Do
----------------------------------------------------------------------------------------------------------------
Import: Radiation-Producing Electronic Products (FDA 89-8008) Do
----------------------------------------------------------------------------------------------------------------
Unsafe Patient Lead Wires and Cables Do
----------------------------------------------------------------------------------------------------------------
Application of a Variance from 21 CFR 1040.11(c) for a Laser Light Do
Show, Display, or Device (Form FDA 3147)
----------------------------------------------------------------------------------------------------------------
Letter to Trade Association: Reuse of Single-Use or Disposable Do
Medical Devices
----------------------------------------------------------------------------------------------------------------
[[Page 41533]]
Design Control Guidance for Medical Device Manufacturers Do
----------------------------------------------------------------------------------------------------------------
Keeping Medical Devices Safe From Electromagnetic Interference Do
----------------------------------------------------------------------------------------------------------------
Safety of Electrically Powered Products: Letter to Medical Devices Do
and Electronic Products Manufacturers From Lilliam Gill and Bruce
H. Burlington Correction Memo
----------------------------------------------------------------------------------------------------------------
Enforcement Priorities for Single-Use Deices Reprocessed by Third Do
Parties and Hospitals: Guidance for Industry and for FDA Staff
----------------------------------------------------------------------------------------------------------------
Labeling for Electronic Anti-Theft Systems; Guidance for Industry; Do
Final
----------------------------------------------------------------------------------------------------------------
Wireless Medical Telemetry Risks and Recommendations, Guidance for Do
Industry; Final
----------------------------------------------------------------------------------------------------------------
Policy on Warning Label Required on Sunlamp Products Do
----------------------------------------------------------------------------------------------------------------
Policy on Lamp Compatibility (Sunlamps) Do
================================================================================================================
Office of Science and Technology
================================================================================================================
Perspectives on Clinical Studies for Medical Device Submissions Do
(Statistical)
----------------------------------------------------------------------------------------------------------------
Guidance on Frequently Asked Questions on Recognition of Consensus Do
Standards (Food and Drug Administration Modernization Act)
----------------------------------------------------------------------------------------------------------------
Guidance on the Recognition and Use of Consensus Standards/ Do
Appendix A (Food and Drug Administration Modernization Act)
----------------------------------------------------------------------------------------------------------------
Center for Devices and Radiological Health Standard Operating Do
Procedures for the Identification and Evaluation of Candidate
Consensus Standard for Recognition
----------------------------------------------------------------------------------------------------------------
Guidance for Industry and FDA Reviewers: Guidance on Do
Immunotoxicity Testing
¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬
IV. CENTER FOR DRUG EVALUATION AND RESEARCH (CDER)
¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬
CATEGORY--ADVERTISING
================================================================================================================
Promotion of Combination Oral Contraceptive Products Nancy E. Derr, Center for Drug Evaluation
and Research (HFD-5), Food and Drug
Administration, 5515 Security Lane,
Rockville, MD 20852, 301-594-5400
================================================================================================================
CATEGORY--CHEMISTRY
================================================================================================================
Documentation for Antibiotics and Other Cellular Metabolites Do
Produced by Microorganisms Modified Using Recombinant DNA
Technology
================================================================================================================
CATEGORY--CLINICAL/MEDICAL
================================================================================================================
Acne Vulgaris Do
----------------------------------------------------------------------------------------------------------------
Ankylosing Spondylitis Do
----------------------------------------------------------------------------------------------------------------
Antifungal Do
----------------------------------------------------------------------------------------------------------------
Chemoprevention of Sporadic Colorectal Adenomas Do
----------------------------------------------------------------------------------------------------------------
Clinical Evaluation of Analgesic Drug Products Do
----------------------------------------------------------------------------------------------------------------
Clinical Evaluation of Drugs for Neuropathic Pain Do
----------------------------------------------------------------------------------------------------------------
Clinical Evaluation of Drugs for Neuropathy Do
----------------------------------------------------------------------------------------------------------------
Clinical Evaluation of Opiate Analgesic Drug Products Do
----------------------------------------------------------------------------------------------------------------
Clinical Trial Design for the Treatment of Allergic Conjunctivitis Do
----------------------------------------------------------------------------------------------------------------
Clinical Trial Design for the Treatment of Bacterial Blepharitis Do
----------------------------------------------------------------------------------------------------------------
Clinical Trial Design for the Treatment of Bacterial Do
Conjunctivitis
----------------------------------------------------------------------------------------------------------------
Clinical Trial Design for the Treatment of Choroidal Do
Neovascularization
----------------------------------------------------------------------------------------------------------------
Clinical Trial Design for the Treatment of Diabetic Macular Edema Do
----------------------------------------------------------------------------------------------------------------
[[Page 41534]]
Clinical Trial Design for the Treatment of Diabetic Retinopathy Do
----------------------------------------------------------------------------------------------------------------
Clinical Trial Design for the Treatment of Dry Eye Do
----------------------------------------------------------------------------------------------------------------
Clinical Trial Design for the Treatment of Elevated Intraocular Do
Pressure
----------------------------------------------------------------------------------------------------------------
Clinical Trail Design for the Treatment of Iritis Do
----------------------------------------------------------------------------------------------------------------
Clinical Trail Design for the Treatment of Macular Edema Do
(Secondary to Inflammation)
----------------------------------------------------------------------------------------------------------------
Clinical Trail Design for the Treatment of Macular Edema Do
(Secondary to a Vascular Event)
----------------------------------------------------------------------------------------------------------------
Clinical Trail Design for the Treatment of Post-Cataract Do
Inflammation
----------------------------------------------------------------------------------------------------------------
Clinical Trail Design for the Treatment of Posterior Uveitis Do
----------------------------------------------------------------------------------------------------------------
Clinical Trial Design for the Treatment of Superficial Punctate Do
Keratitis
----------------------------------------------------------------------------------------------------------------
Chemistry, Manufacturing, and Control, Preclinical, and Clinical Do
Development of Decorporation Agents for the Treatment of Internal
Radioactive Contamination
----------------------------------------------------------------------------------------------------------------
Corticosteroid Induced Adrenal Suppression Do
----------------------------------------------------------------------------------------------------------------
Development of Drugs for Chronic Obstructive Pulmonary Disease Do
----------------------------------------------------------------------------------------------------------------
Developing Antiviral Drugs for the Treatment of Smallpox Do
----------------------------------------------------------------------------------------------------------------
Drug-Coated Cardiovascular Stents Do
----------------------------------------------------------------------------------------------------------------
Evaluation of New Treatments for Diabetes Mellitus Do
----------------------------------------------------------------------------------------------------------------
Gingivitis Do
----------------------------------------------------------------------------------------------------------------
Intraocular Pressure Lowering Do
----------------------------------------------------------------------------------------------------------------
Oral Mucositis Do
----------------------------------------------------------------------------------------------------------------
Patient Reported Outcomes Do
----------------------------------------------------------------------------------------------------------------
Periodontitis Do
----------------------------------------------------------------------------------------------------------------
Psoriasis Do
----------------------------------------------------------------------------------------------------------------
Safety Review of Clinical Data Do
----------------------------------------------------------------------------------------------------------------
System Lupus Erythematosus Do
----------------------------------------------------------------------------------------------------------------
Premarketing Risk Assessment Do
----------------------------------------------------------------------------------------------------------------
Development and Use of Risk Minimization Action Plans Do
----------------------------------------------------------------------------------------------------------------
Good Pharmacovigilance Practices and Pharmacoepidemiologic Do
Assessment
----------------------------------------------------------------------------------------------------------------
Coronary Drug-Eluting Stents Do
----------------------------------------------------------------------------------------------------------------
Pharmacogenomic Combination Products Do
----------------------------------------------------------------------------------------------------------------
42. Centralized Institutional Review Boards in Multi-Center Trials Do
================================================================================================================
CATEGORY--CLINICAL/PHARMACOLOGY
================================================================================================================
Clinical Lactation Studies--Study Design, Data Analysis, and Do
Recommendations for Labeling
----------------------------------------------------------------------------------------------------------------
Immediate Release to Modified Release Dosage Forms Do
----------------------------------------------------------------------------------------------------------------
In Vitro Drug Metabolism/Drug Interaction--Guidance for Reviewers Do
----------------------------------------------------------------------------------------------------------------
Pharmacokinetics in Pregnancy--Study Design, Data Analysis, and Do
Impact on Dosing and Labeling
================================================================================================================
CATEGORY--COMPLIANCE
================================================================================================================
[[Page 41535]]
Describing How Positron Emission Tomography Drug Products May Do
Comply With New Current Good Manufacturing Practice Requirements
----------------------------------------------------------------------------------------------------------------
Expiration Dating of Unit-Dose Repackaged Drugs Do
----------------------------------------------------------------------------------------------------------------
Maintaining Adequate and Accurate Records During Clinical Do
Investigations
----------------------------------------------------------------------------------------------------------------
Current Good Manufacturing Practice For Investigational New Drug Do
and Biological Products--Phase I Testing
================================================================================================================
CATEGORY--ELECTRONIC SUBMISSIONS
================================================================================================================
Standards for Clinical Data Submissions Do
================================================================================================================
CATEGORY--GENERICS
================================================================================================================
Abbreviated New Drug Applications Suitability Petitions Do
----------------------------------------------------------------------------------------------------------------
Bioequivalence Studies with Clinical Endpoints for Vaginal Do
Antifungal Drug Products
----------------------------------------------------------------------------------------------------------------
Defining the Term ``Listed Drug'' With Respect to Amendments and Do
Supplements to Abbreviated New Drug Applications and Section
505(b)(2) Applications
----------------------------------------------------------------------------------------------------------------
Abbreviated New Drug Applications: Pharmaceutical Solid Do
Polymorphism
================================================================================================================
CATEGORY--GOOD REVIEW PRACTICES
================================================================================================================
General Clinical Review Template Do
================================================================================================================
CATEGORY--INVESTIGATIONAL NEW DRUG APPLICATION
================================================================================================================
Consumer Product Safety Commission--Tamper Resistant Packaging for Do
Investigational New Drugs
----------------------------------------------------------------------------------------------------------------
End of Phase 2 Meetings Do
----------------------------------------------------------------------------------------------------------------
Pediatric Safety and Efficacy Data in Investigational New Drugs Do
----------------------------------------------------------------------------------------------------------------
Exploratory Investigational New Drugs: Preclinical and Clinical Do
Considerations
================================================================================================================
CATEGORY--LABELING
================================================================================================================
Content and Format of the Clinical Pharmacology Section Do
----------------------------------------------------------------------------------------------------------------
Content and Format of the Dosage and Administration Section of the Do
Prescription Drug Labeling
----------------------------------------------------------------------------------------------------------------
Content and Format of the Warnings and Precautions, Do
Contraindications, and Boxed Warning Sections of Prescription
Drug Labeling
----------------------------------------------------------------------------------------------------------------
Drug Names and Dosage Forms Do
----------------------------------------------------------------------------------------------------------------
Implementing the New Content and Format Requirements for Do
Prescription Drug Labeling
----------------------------------------------------------------------------------------------------------------
Labeling Dietary Supplements for Women Who Are or Could Be Do
Pregnant
----------------------------------------------------------------------------------------------------------------
Pregnancy Labeling Revisions Do
----------------------------------------------------------------------------------------------------------------
Submitting Proprietary Names for Evaluation Do
================================================================================================================
CATEGORY--OVER-THE-COUNTER
================================================================================================================
Actual Use Trials Do
----------------------------------------------------------------------------------------------------------------
Labeling Comprehension Studies for Over-the-Counter Drug Products Do
----------------------------------------------------------------------------------------------------------------
Labeling for Over-the-Counter Human Drug Products Do
----------------------------------------------------------------------------------------------------------------
Labeling of Over-the-Counter Skin Protectant Products Do
----------------------------------------------------------------------------------------------------------------
Labeling Over-the-Counter Human Drug Products; Questions and Do
Answers
================================================================================================================
CATEGORY--PHARMACOLOGY/TOXICOLOGY
================================================================================================================
[[Page 41536]]
Drug-Induced Vascular Injury Do
================================================================================================================
CATEGORY--PROCEDURAL
================================================================================================================
Assessment of Abuse Potential of Drugs Do
----------------------------------------------------------------------------------------------------------------
Development of a Drug and Pharmacogenetic Test Do
----------------------------------------------------------------------------------------------------------------
Dispute Resolution Involving Pediatric Labeling Do
----------------------------------------------------------------------------------------------------------------
Exocrine Pancreatic Insufficiency Drug Products--Submitting New Do
Drug Applications
----------------------------------------------------------------------------------------------------------------
How to Comply With the Pediatric Research Equity Act Do
----------------------------------------------------------------------------------------------------------------
How to Determine if Human Research With a Radioactive Drug Can Be Do
Conducted Under a Radioactive Drug Research Committee
----------------------------------------------------------------------------------------------------------------
Process for Contracts and Written Requests Under the Best Do
Pharmaceutical for Children Act
----------------------------------------------------------------------------------------------------------------
Qualifying for Pediatric Exclusivity Under Section 505A of the Do
Federal Food, Drug, and Cosmetic Act
¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬
V. Center for Food Safety and Applied Nutrition (CFSAN)
¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬
CATEGORY--DIETARY SUPPLEMENTS
================================================================================================================
Labeling Dietary Supplements for Women Who Are or Could Be Linda Pellicore, Center for Food Safety
Pregnant and Applied Nutrition (HFS-810), Food and
Drug Administration, 5100 Paint Branch
Pkwy., College Park, MD 20740, 301-436-
1448, FAX 301-436-2636,
Linda.Pellicore@cfsan.fda.gov
----------------------------------------------------------------------------------------------------------------
Dietary Supplements: 75-Day Premarket Notifications for New Do
Dietary Ingredients
----------------------------------------------------------------------------------------------------------------
Substantiation Health Claims Guidance Do
================================================================================================================
CATEGORY--FOOD ADDITIVE SAFETY
================================================================================================================
Final Guidance on Electronic Submissions of Food and Color George Pauli, Center for Food Safety and
Additive Petitions (Level 1) Applied Nutrition (HFS-200), Food and
Drug Administration, 5100 Paint Branch
Pkwy., College Park, MD 20740
----------------------------------------------------------------------------------------------------------------
Presence of Unintended Varieties of Bioengineered Plant Foods in Do
the Food Supply (Level 1)
----------------------------------------------------------------------------------------------------------------
Chloropropanols Compliance Policy Guides Guidance Do
================================================================================================================
CATEGORY--CONSTITUENT OPERATIONS
================================================================================================================
Equivalence Level 1 Guidance Cathy Carneval, Center for Food Safety and
Applied Nutrition (HFS-550), Food and
Drug Administration, 5100 Paint Branch
Pkwy., College Park, MD 20740
================================================================================================================
CATEGORY--OFFICE OF COMPLIANCE
================================================================================================================
Prior Notice of Imported Food Products--Questions and Answers May Nelson, Center for Food Safety and
Applied Nutrition (HFS-22), Food and Drug
Administration, 5100 Paint Branch Pkwy.,
College Park, MD 20740
¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬
VI. CENTER FOR VETERINARY MEDICINE (CVM)
¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬
CATEGORY--NEW ANIMAL DRUG APPLICATIONS
================================================================================================================
Administrative New Animal Drug Application Process (132) Gail Schmerfeld, Center for Veterinary
Medicine (HFV-100), Food and Drug
Administration, 7500 Standish Pl., rm.
384, Metropark North II, Rockville, MD
20855, 301-827-1796, gschmer1@cvm.fda.gov
----------------------------------------------------------------------------------------------------------------
[[Page 41537]]
Waivers of In Vivo Demonstration of Bioequivalence of Certain Marilyn Martinez, Center for Veterinary
Animal Drugs in Soluble Powder Oral Dosage Form Products and Type Medicine (HFV-130), Food and Drug
A Medicated Articles (171) Administration, 7500 Standish Pl., rm.
332, Metropark North II, Rockville, MD
20855, 301-827-7577, mmartin1@cvm.fda.gov
================================================================================================================
CATEGORY--LABELING
================================================================================================================
Manufacture and Labeling of Raw Meat Diets for Consumption by William Burkholder, Center for Veterinary
Dogs, Cats, and Captive Noncompanion Animal Carnivores and Medicine (HFV-228), Food and Drug
Omnivores (122) Administration, 7500 Standish Pl., rm.
413, Metropark North II, Rockville, MD
20855, 301-827-0179, bburkhol@cvm.fda.gov
----------------------------------------------------------------------------------------------------------------
Content and Format for Labeling of New Animal Drug Products Douglass Oeller, Center for Veterinary
(134) Medicine (HFV-112), Food and Drug
Administration, 7500 Standish Pl., rm.
324, Metropark North II, Rockville, MD
20855, 301-827-0131, doeller@cvm.fda.gov
================================================================================================================
CATEGORY--STATUTORY REQUIREMENTS
================================================================================================================
Dispute Resolution--FDA Modernization Act (79) Marcia Larkins, Center for Veterinary
Medicine (HFV-1), Food and Drug
Administration, 7519 Standish Pl., rm.
165, Metropark North IV, Rockville, MD
20855, 301-827-4535, mlarkins@cvm.fda.gov
----------------------------------------------------------------------------------------------------------------
Animal Drug Sponsor Fees Under the Animal Drug User Fee Act David Newkirk, Center for Veterinary
(173) Medicine (HFV-100), Food and Drug
Administration, 7500 Standish Pl., rm.
390, Metropark North II, Rockville, MD
20855, 301-827-6967, dnewkirk@cvm.fda.gov
----------------------------------------------------------------------------------------------------------------
Chemistry, Manufacturing, and Control Changes to an Approved New Dennis Bensley, Center for Veterinary
Animal Drug Application or Abbreviated New Drug Applications Medicine (HFV-143), Food and Drug
(83) Administration, 7500 Standish Pl., rm.
320, Metropark North II, Rockville, MD
20855, 301-827-6956, dbensley@cvm.fda.gov
================================================================================================================
CATEGORY--INTERNATIONAL HARMONIZATION
================================================================================================================
GL-27: Preapproval Information for Registration of New Veterinary William T. Flynn, Center for Veterinary
Medicinal Products for Food-Producing Animals With Respect to Medicine (HFV-2), Food and Drug
Antimicrobial Resistance (144) Administration, 7519 Standish Pl., rm.
173, Metropark North IV, Rockville, MD
20855, 301-827-4514, wflynn@cvm.fda.gov
----------------------------------------------------------------------------------------------------------------
GL-28: Studies to Evaluate the Safety of Residues of Veterinary Thomas Mulligan, Center for Veterinary
Drugs in Human Food: Carcinogenicity Testing (141) Medicine (HFV-153), Food and Drug
Administration, rm. E375, Metropark North
II, 7500 Standish Pl., Rockville, MD
20855, 301-827-6984, tmulliga@cvm.fda.gov
----------------------------------------------------------------------------------------------------------------
GL-33: Studies to Evaluate the Safety of Residues of Veterinary Do
Drugs in Human Food: General Approach to Testing (149)
----------------------------------------------------------------------------------------------------------------
GL-36: Studies to Evaluate the Safety of Residues of Veterinary Do
Drugs in Human Food: General Approach to Establish a
Microbiological Acceptable Daily Intake (159)
----------------------------------------------------------------------------------------------------------------
GL-37 Studies to Evaluate the Safety of Residues of Veterinary Do
Drugs in Human Food: Repeat-Dose (Chronic) Toxicity Testing
(160)
----------------------------------------------------------------------------------------------------------------
GL-38 Environmental Impact Assessments for Veterinary Medicinal Charles Eirkson, Center for Veterinary
Products--Phase II (166) Medicine (HFV-103), Food and Drug
Administration, rm. 137, Metropark North
IV, 7500 Standish Pl., Rockville, MD
20855, 301-827-8561, ceirkson@cvm.fda.gov
================================================================================================================
CATEGORY--TARGET ANIMAL SAFETY AND EFFECTIVENESS
================================================================================================================
[[Page 41538]]
Development of Target Animal Safety and Effectiveness Data to Linda Wilmot, Center for Veterinary
Support Approval of Non-Steroidal Anti-Inflammatory Drugs for Use Medicine (HFV-114), Food and Drug
in Animals (123) Administration, 7500 Standish Pl., rm.
N316, Metropark North II, Rockville, MD
20855, 301-827-0135, lwilmot@cvm.fda.gov
================================================================================================================
CATEGORY--HUMAN FOOD SAFETY
================================================================================================================
Dioxin in Minerals Used in Animal Feed (161) Gloria Dunnavan, Center for Veterinary
Medicine (HFV-230), Food and Drug
Administration, 7500 Standish Pl., rm.
E480, Metropark North II, Rockville, MD
20855, 301-827-1168, gdunnava@cvm.fda.gov
----------------------------------------------------------------------------------------------------------------
Salmonella Contamination of Feeds Compliance Policy Guide Henry Ekperigin, Center for Veterinary
Medicine (HFV-222), Food and Drug
Administration, 7500 Standish Pl., rm.
E417, Metropark North II, Rockville, MD
20855, 301-827-0174, hekperig@cvm.fda.gov
----------------------------------------------------------------------------------------------------------------
Bovine Spongiform Encephalopathies Compliance Program Neal Bataller, Center for Veterinary
Medicine (HFV-230), Food and Drug
Administration, 7500 Standish Pl., rm.
E441, Metropark North II, Rockville, MD
20855, 301-827-0163, nbatalle@cvm.fda.gov
----------------------------------------------------------------------------------------------------------------
Validation of Analytical Procedures for Type C Medicated Feed Mary G. Leadbetter, Center for Veterinary
(135) Medicine (HFV-141), Food and Drug
Administration, 7500 Standish Pl., rm.
E307, Metropark North II, Rockville, MD
20855, 301-827-6964, mleadbet@cvm.fda.gov
¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬
VII. OFICE OF REGULATORY AFFAIRS (ORA)
¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬
CATEGORY--COMPLIANCE AND INSPECTION
================================================================================================================
Guidance for Investigators: Investigations Operations Manual Michael Rogers, Division of Field
Investigations (HFC-130), Food and Drug
Administration, 5600 Fishers Lane, rm. 13-
74, Rockville, MD 20857, 301-827-5653
================================================================================================================
CATEGORY--REGULATORY
================================================================================================================
Guidance for Food and Drug Administration Staff: Regulatory Paul Motise, Division of Compliance
Information Assurance; Good Practices in Converting From Paper to Information and Quality Assurance (HFC-
Electronic Processes 240), Food and Drug Administration, 1350
Piccard Dr., Rockville, MD 20850, 301-827-
0383
================================================================================================================
CATEGORY--COMPLIANCE AND INSPECTIONS
================================================================================================================
Concept Paper on Bioterrorism Act Proposed Guidance to Records Rudaina Alrefai, Division of Compliance
Access Information and Quality Assurance (HFC-
240), Food and Drug Administration, 1350
Piccard Dr., rm. 400L, Rockville, MD
20850, 301-827-0413
================================================================================================================
CATEGORY--GUIDANCE FOR INDUSTRY AND FOOD AND DRUG ADMINISTRATION STAFF
================================================================================================================
21 CFR Part 58: Good Laboratory Practice, Questions and Answers James McCormack, Division of Compliance
Policy (HFC-230), Food and Drug
Administration, 1350 Piccard Dr., rm.
400Z, Rockville, MD 20850, 301-827-0425
================================================================================================================
21 CFR Part 58: Closure of Nonclinical Laboratories Rodney Allnutt, Division of Compliance
Policy (HFC-230), Food and Drug
Administration, 1350 Piccard Dr., rm.
400Y, Rockville, MD 20850, 301-827-8860
----------------------------------------------------------------------------------------------------------------
21 CFR Part 58: Comparison of the Food and Drug Administration, James McCormack, Division of Compliance
Environmental Protection Agency, and the Organisation for Policy (HFC-230), Food and Drug
Economic and Cooperative Development Good Laboratory Practices Administration, 1350 Piccard Dr., rm.
400Z, Rockville MD 20850, 301-827-0425.
================================================================================================================
CATEGORY--GUIDANCE FOR INDUSTRY AND FOOD AND DRUG ADMINISTRATION INVESTIGATORS
================================================================================================================
[[Page 41539]]
Auditing Nonclinical Laboratory Studies Do
================================================================================================================
CATEGORY--GUIDANCE FOR FOOD AND DRUG ADMINISTRATION INVESTIGATORS
================================================================================================================
Necropsy, Tissue Preparation, and Histology in Nonclinical Do
Laboratory Studies
================================================================================================================
CATEGORY--COMPLIANCE POLICY GUIDE
================================================================================================================
Section 394.500, Importation of Television Products, Microwave Jeffrey Governale, Division of Compliance
Ovens, and Inherent Class I Laser Products for Investigation and Policy (HFC-230), Food and Drug
Evaluation during Design Development (CPG 7133.22) Administration, 1350 Piccard Dr., rm.
410A, Rockville, MD 20850, 301-827-0411
----------------------------------------------------------------------------------------------------------------
Section 300.500, Reprocessing and Reuse of Single Use Devices (CPG Do
7124.16)
----------------------------------------------------------------------------------------------------------------
Section 310.210, Blood Pressure Measurement Devices Do
(Sphygmomanometers)--Accuracy (CPG 7124.23)
================================================================================================================
CATEGORY--REGULATORY POLICY MANUAL
================================================================================================================
Subchapter, Disqualification of Clinical Investigators James McCormack, Division of Compliance
Policy (HFC-230), Food and Drug
Administration, 1350 Piccard Dr., rm.
400Z, Rockville, MD 20850, 301-827-0425
================================================================================================================
CATEGORY--REGULATORY POLICY MANUAL SUBCHAPTER OR STAFF MANUAL GUIDE
================================================================================================================
Untrue Statements of Material Facts Sharon Sheehan, Division of Compliance
Policy (HFC-230), Food and Drug
Administration, 1350 Piccard Dr., rm.
450, Rockville, MD 20850, 301-827-0412
================================================================================================================
CATEGORY--REGULATORY POLICY MANUAL SUBCHAPTER
================================================================================================================
Application Integrity Policy Do
================================================================================================================
CATEGORY--REGULATORY PROCEDURES MANUAL
================================================================================================================
Chapter 9 Imports Carl Nielsen, Division of Import
Operations (HFC-170), Food and Drug
Administration, 5600 Fishers Lane, rm. 12-
38, Rockville, MD 20857, 301-443-6553
¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬
VIII. OFFICE OF THE COMMISSIONER (OC)
¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬
CATEGORY--COMPLIANCE
================================================================================================================
Guidance for Industry Information Sheets for Institutional Review David Lepay, Good Clinical Practice
Boards and Clinical Investigators Program (HF-34), Office of Science and
Health Coordination, Food and Drug
Administration, 5600 Fishers Lane, rm.
9C24, Rockville, MD 20857
----------------------------------------------------------------------------------------------------------------
Guidance for Industry Computerized Systems Used in Clinical Trials Do
================================================================================================================
CATEGORY--INSPECTION
================================================================================================================
Guidance for FDA Staff Compliance Program 7348.811, Inspection of Do
Clinical Investigators and Sponsor Investigators
----------------------------------------------------------------------------------------------------------------
[[Page 41540]]
Dated: June 30, 2004.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 04-15660 Filed 7-8-04; 8:45 am]
BILLING CODE 4160-01-S