Draft Guidance for Industry and Food and Drug Administration Staff - Refuse to Accept Policy for 510(k)s (PDF - 1.4MB)
|
CDRH CBER
|
1793
|
08/13/12
|
Guidance for Industry and Food and Drug Administration Staff and Foreign Governments - FY 2013 Medical Device User Fee Small Business Qualification and Certification (PDF - 365KB)
|
CDRH CBER
|
2013
|
08/01/12
|
Draft Guidance for Industry and Food and Drug Administration Staff - Acceptance and Filing Review for Premarket Approval Applications (PMAs) (PDF - 669KB)
|
CDRH CBER
|
1792
|
07/31/12
|
Draft Guidance for Industry and FDA Staff Medical Devices: The Pre-Submission Program and Meetings with FDA Staff
|
CDRH CBER
|
1677
|
07/13/12
|
Considerations When Transferring Clinical Investigation Oversight to Another IRB
|
Draft Guidance for IRBs, Clinical Investigators and Sponsors - Considerations When Transferring Clinical Investigation Oversight to Another IRB
|
|
06/12/12
|
Guidance for Industry and Food and Drug Administration Staff - FDA and Industry Procedures for Section 513(g) Requests for Information under the Federal Food, Drug, and Cosmetic Act
|
CDRH CBER
|
1671
|
04/06/12
|
Guidance for Industry and Food and Drug Administration Staff - User Fees for 513(g) Requests for Information
|
CDRH CBER
|
1709
|
04/06/12
|
Guidance for Industry and FDA Staff - Factors to Consider When Making Benefit-Risk Determinations in Medical Device Premarket Approval and De Novo Classifications (PDF - 523KB)
|
ODE OIVD
|
1772
|
03/29/12
|
Guidance for Industry, Third Parties and Food and Drug Administration Staff - Medical Device ISO 13485:2003 Voluntary Audit Report Submission Pilot Program
|
CBER CDRH
|
1764
|
03/19/12
|
Draft Guidance for Industry - Providing Submissions in Electronic Format -- Standardized Study Data (PDF - 539KB)
|
Electronic Submissions
|
|
02/17/12
|
Guidance for Industry: Preparation of IDEs and INDs for Products Intended to Repair or Replace Knee Cartilage (PDF - 157KB)
|
|
|
|
Draft Guidance for Industry and Food and Drug Administration Staff - Medical Device Classification Product Codes
|
CDRH CBER
|
1774
|
01/03/12
|
Draft Guidance for Industry and Food and Drug Administration Staff - The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)]
|
CDRH/ODE CBER
|
1766
|
12/27/11
|
Draft Guidance- Humanitarian Use Device (HUD) Designations (PDF - 79KB)
|
FDA Staff- Humanitarian Use Device (HUD) Designations; HDE, HUD
|
|
|
Draft Guidance for Industry, Clinical Investigators, Institutional Review Boards, and Food and Drug Administration Staff - FDA Decisions for Investigational Device Exemption (IDE) Clinical Investigations
|
CDRH CBER
|
1783
|
11/10/11
|
Draft Guidance for Industry and Food and Drug Administration Staff - De Novo Classification Process (Evaluation of Automatic Class III Designation)
|
CDRH CBER
|
1760
|
10/03/11
|
Oversight of Clinical Investigations — A Risk-Based Approach to Monitoring (PDF - 149KB)
|
Procedural
|
|
08/29/11
|
Guidance for Industry and Food and Drug Administration Staff - Factors to Consider When Making Benefit-Risk Determinations in Medical Device Premarket Approvals and De Novo Classifications
|
CDRH CBER
|
1772
|
08/15/11
|
Draft Guidance for Industry, Clinical Investigators, and Food and Drug Administration Staff - Design Considerations for Pivotal Clinical Investigations for Medical Devices
|
CDRH/ODE CDRH/OIVD CBER
|
1776
|
08/15/11
|
Guidance for Industry and Food and Drug Administration Staff and Foreign Governments - FY 2012 Medical Device User Fee Small Business Qualification and Certification (PDF - 547KB)
|
CDRH CBER
|
2012
|
08/01/11
|
(Withdrawn) Guidance for Industry and FDA Staff - 510(k) Device Modifications: Deciding When to Submit a 510(k) for a Change to an Existing Device
|
CDRH CBER
|
1793
|
07/27/11
|
Draft Guidance for Industry and Food and Drug Administration Staff - Mobile Medical Applications
|
CDRH CBER
|
1741
|
07/21/11
|
Draft Guidance for Industry and Food and Drug Administration Staff - In Vitro Companion Diagnostic Devices
|
CDRH CBER CDER
|
1737
|
07/14/11
|
Draft Guidance for Industry and FDA Staff - Commercially Distributed In Vitro Diagnostic Products Labeled for Research Use Only or Investigational Use Only: Frequently Asked Questions
|
CDRH/OIVD CBER
|
1723
|
06/01/11
|
Draft Guidance for Industry and FDA Staff - Processing/Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling
|
CDRH/ODE CBER
|
1644
|
05/02/11
|
Guidance for Industry and FDA Staff - 30-Day Notices, 135-Day Premarket Approval (PMA) Supplements and 75-Day Humanitarian Device Exemption (HDE) Supplements for Manufacturing Method or Process Changes
|
CDRH/OC CBER
|
1687
|
04/13/11
|
Electronic Source Documentation in Clinical Investigations (PDF - 166KB)
|
Procedural; Electronic Submissions
|
|
01/06/11
|
Guidance for Industry: Cellular Therapy for Cardiac Disease
|
CBER/CDRH
|
|
11/04/10
|
Guidance for HDE Holders, Institutional Review Boards (IRBs), Clinical Investigators, and FDA Staff - Humanitarian Device Exemption (HDE) Regulation: Questions and Answers
|
CBER
CDRH
|
1668
|
07/08/10
|
Guidance for Industry and FDA Staff: In Vitro Diagnostic (IVD) Device Studies - Frequently Asked Questions (PDF - 352KB)
|
CBER CDRH/OIVD
|
1587
|
06/25/10
|
Guidance for Industry and FDA Staff - User Fees and Refunds for Premarket Notification Submissions (510(k)s)
|
CBER
CDRH
|
1511
|
08/27/09
|
Guidance for Industry, FDA Staff, and Third Parties - Inspection by Accredited Persons Under The Medical Device User Fee and Modernization Act of 2002 and the FDA Amendments Act of 2007; Accreditation Criteria
|
CBER
CDRH
|
1200
|
08/06/09
|
Presenting Risk Information in Prescription Drug and Medical Device Promotion (PDF - 377KB)
|
Advertising
|
|
05/27/09
|
User Fees and Refunds for Premarket Approval Applications
|
CBER
CDRH
|
1681
|
03/13/09
|
Guidance for Industry, FDA Staff, and FDA-Accredited Third Parties - Manufacturer's Notification of the Intent to Use an Accredited Person under the Accredited Persons Inspection Program Authorized by Section 228 of the Food and Drug Administration Amendments Act of 2007 (FDAAA)
|
CBER
CDRH
|
1532
|
03/02/09
|
Assay Migration Studies for In Vitro Diagnostic Devices
|
CBER
CDRH/OIVD
|
1660
|
01/05/09
|
Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile
|
CBER
CDRH/ODE
|
1615
|
12/12/08
|
Modifications to Devices Subject to Premarket Approval (PMA) - The PMA Supplement Decision
|
CBER
CDRH
|
1584
|
12/11/08
|
FDA and Industry Actions on Premarket Approval Applications (PMAs): Effect on FDA Review Clock and Goals
|
CBER
CDRH
|
1218
|
06/30/08
|
Coronary Drug-Eluting Stents-Nonclinical and Clinical Studies (PDF - 398KB)
|
|
|
|
Coronary Drug-Eluting Stents — Nonclinical and Clinical Studies -Companion Document (PDF - 221KB)
|
|
|
|
Guidance for Industry and FDA Staff: Expedited Review of Premarket Submissions for Devices
|
CBER
CDRH
|
108
|
02/29/08
|
Interactive Review for Medical Device Submissions: 510(k)s, Original PMAs, PMA Supplements, Original BLAs, and BLA Supplements
|
CBER
CDRH
|
1655
|
02/28/08
|
Guidance for Industry and FDA Staff: Bundling Multiple Devices or Multiple Indications in a Single Submission
|
CBER
CDRH
|
1215
|
06/22/07
|
Guidance on Pharmacogenetic Tests and Genetic Tests for Heritable Markers
|
CBER
CDER
CDRH
|
1549
|
02/09/06
|
Annual Reports for Approved Premarket Approval Applications (PMA)
|
CBER
CDRH
|
1585
|
10/26/06
|
Real-Time Premarket Approval Application (PMA) Supplements
|
CBER
CDRH
|
673
|
04/28/06
|
Informed Consent for In Vitro Diagnostic Device Studies Using Leftover Human Specimens that are Not Individually Identifiable
|
CBER
CDRH
|
1588
|
04/25/06
|
Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices
|
CBER
CDRH/ODE
CDRH/OIVD
|
337
|
05/11/05
|
Use of Symbols on Labels and in Labeling of In Vitro Diagnostic Devices Intended for Professional Use
|
CBER
CDRH
|
4444
|
11/30/04
|
Resolution of Disputes Concerning Payment or Refund of Medical Device User Fees Under MDUFMA
|
CBER
CDRH
|
1303
|
11/17/04
|
Guidance for Industry and FDA Staff - User Fees and Refunds for Premarket Notification Submissions (510(k)s)
|
CBER
CDRH
|
1511
|
08/27/09
|
FDA and Industry Actions on Premarket Notification (510(k)) Submissions: Effect on FDA Review Clock and Performance Assessment
|
CBER
CDRH
|
1219
|
05/21/04
|
Premarket Assessment of Pediatric Medical Devices
|
CBER
CDRH
|
1220
|
05/14/04
|
Guidance for Industry and FDA: User Fees and Refunds for Premarket Approval Applications
|
CBER
CDRH
|
1224
|
11/24/03
|
Premarket Approval Application Modular Review
|
CBER
CDRH/ODE
|
835
|
11/03/03
|
Premarket Approval Application Filing Review
|
CBER
CDRH/ODE
CDRH/OIVD
|
297
|
05/01/03
|
Assessing User Fees: PMA Supplement Definitions, Modular PMA Fees, BLA and Efficacy Supplement Definitions, Bundling Multiple Devices in a Single Application, and Fees for Combination Products
|
CBER
CDRH
|
1201
|
02/25/03
|
The Least Burdensome Provisions of the FDA Modernization Act of 1997: Concept and Principles; Final Guidance for FDA and Industry
|
CBER
CDRH/ODE
|
1332
|
10/04/02
|
General Principles of Software Validation; Final Guidance for Industry and FDA Staff
|
CBER
CDRH/OC
|
938
|
01/11/02
|