PMA Guidance Documents

Alphabetical Listing of PMA Guidance Documents

• 30-Day Notices, 135-Day Premarket Approval (PMA) Supplements and 75-Day Humanitarian Device Exemption (HDE) Supplements for Manufacturing Method or Process Changes - Guidance for Industry and FDA Staff
• FDA Acceptance of Clinical Data to Support Medical Device Applications and Submissions Frequently Asked Questions
• Bioresearch Monitoring Agreement for PMAs and PDPs - February 23, 1998
• Color Additive Petitions
• Early Collaboration Meetings Under the FDA Modernization Act (FDAMA); Final Guidance for Industry and for CDRH Staff
• Guidance for Industry and FDA Staff - Statistical Guidance on Reporting Results from Studies Evaluating Diagnostic Tests
• Bundling Multiple Devices or Multiple Indications in a Single Submission - Guidance for Industry and FDA Staff
• Guidance on PMA Interactive Procedures for Day-100 Meetings and Subsequent Deficiencies - for Use by CDRH and Industry
• Guidance for Industry and for FDA Reviewers: Guidance on Section 216 of the Food and Drug Administration Modernization Act of 1997
• Guidance for Industry - Supplements to Approved Applications for Class III Medical Devices: Use of Published Literature, Use of Previously Submitted Materials, and Priority Review (Text Only)
• Procedures for Meetings of the Medical Devices Advisory Committee - Guidance for Industry and Food and Drug Administration Staff
• Post Approval Studies Status
• Guidance for Industry and Food and Drug Administration Staff - Acceptance and Filing Reviews for Premarket Approval Applications (PMAs)
• Premarket Approval Application and Humanitarian Device Exemption Modular Review - Guidance for Industry and FDA Staff
• Premarket Assessment of Pediatric Medical Devices - Guidance for Industry and FDA Staff
• Quality System Information for Certain Premarket Application Reviews - Guidance for Industry and FDA Staff
• Real-Time Premarket Approval Application (PMA) Supplements - Guidance for Industry and FDA Staff
• The Least Burdensome Provisions of the FDA Modernization Act of 1997: Concept and Principles - Final Guidance for FDA and Industry
• User Fees and Refunds for Premarket Approval Applications and Device Biologics License Applications - Guidance for Industry and Food and Drug Administration Staff
• FDA and Industry Actions on Premarket Approval Applications (PMAs): Effect on FDA Review Clock and Goals - Guidance for Industry and Food and Drug Administration Staff
• Modifications to Devices Subject to Premarket Approval (PMA) - The PMA Supplement Decision-Making Process - Guidance for Industry and FDA Staff
• Annual Reports for Approved Premarket Approval Applications (PMA) - Guidance for Industry and Food and Drug Administration Staff (PDF)