Alphabetical Listing of PMA Guidance Documents

• 30-Day Notices and 135-Day PMA Supplements for Manufacturing Method or Process Changes, Guidance for Industry and CDRH 
• Acceptance of Foreign Clinical Studies 
• 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 
• Balloon Valvuloplasty Guidance For The Submission Of an IDE Application and a PMA Application (Text Only) 
• Bioresearch Monitoring Agreement for PMAs and PDPs - February 23, 1998 
• Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Bone Sonometers 
• Color Additive Petitions (PDF Only) (PDF - 91KB) 
• Continued Access to Investigational Devices During PMA Preparation and Review July 15, 1996 (Blue Book Memo) (D96-1) (Text Only) 
• Distribution and Public Availability of Premarket Approval Application Summary of Safety and Effectiveness Data Packages - October 10, 1997 (P97-1) (Text Only) 
• Early Collaboration Meetings Under the FDA Modernization Act (FDAMA); Final Guidance for Industry and for CDRH Staff 
• Guidance for Industry and FDA Staff: Expedited Review of Premarket Submissions for Devices 
• FDA and Industry Actions on Premarket Approval Applications (PMAs): Effect on FDA Review Clock and Goals 
• Guidance Document for the Preparation of IDE and PMA Applications for Intra-Articular Prosthetic Knee Ligament Devices 
• Statistical Guidance on Reporting Results from Studies Evaluating Diagnostic Tests 
• Guidance for Industry and FDA Staff: Bundling Multiple Devices or Multiple Indications in a Single Submission 
• 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) 
• Panel Report and Recommendations on PMA Approvals #P86-5 (blue book memo) (Text Only) 
• Panel Review of Premarket Approval Applications #P91-2 (blue book memo) (Text Only) 
• PMA Compliance Program #P91-3 (blue book memo) (Text Only) 
• Post Approval Studies Status 
• PMA Review Statistical Checklist (PDF Only) (PDF - 69KB) 
• Premarket Approval Application Filing Review 
• Premarket Approval Application Modular Review 
• Premarket Approval Applications (PMA) for Sharps Needle Destruction Devices; Final Guidance for Industry and FDA 
• Premarket Assessment of Pediatric Medical Devices 
• Quality System Information for Certain Premarket Application Reviews; Guidance for Industry and FDA Staff 
• Real-Time Premarket Approval Application (PMA) Supplements 
• The Least Burdensome Provisions of the FDA Modernization Act of 1997: Concept and Principles; Final Guidance for FDA and Industry 
• Threshold Assessment of the Impact of Requirements for Submission of PMAs for 31 Medical Devices Marketed Prior to May 28, 1976 (PDF Only) (PDF - 546KB) 
• Guidance for Industry and FDA: User Fees and Refunds for Premarket Approval Applications