 | PMA Modular Submission Cover Sheet at HIMA Website |
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| 30-Day Notices and 135-Day PMA Supplements for Manufacturing Method or Process Changes (2/19/98) (P98-4) (02/19/1998) |
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| 30-Day Notices and 135-day PMA Supplements for Manufacturing Method or Process Changes, Guidance for Industry and CDRH (Docket 98D-0080); Final (02/19/1998) |
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| Acceptance of Foreign Clinical Studies; Guidance for Industry (03/13/2001) |
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| 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; Guidance for Industry and FDA (02/25/2003) |
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| Balloon Valvuloplasty Guidance For The Submission Of an IDE Application and a PMA Application (01/01/1989) |
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| Bioresearch Monitoring Agreement for PMAs and PDPs (02/23/1998) |
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| Bone Sonometer PMA Applications; Final Guidance for Industry and FDA (06/21/2001) |
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| Bundling Multiple Devices or Multiple Indications in a Single Submission - Guidance for Industry and FDA Staff (11/26/2003) |
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| Color Additive Petitions (p. II-19 of PMA Manual) (06/01/1987) |
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| Continued Access to Investigational Devices During PMA Preparation and Review (Blue Book Memo) (D96-1) (07/15/1996) |
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| Distribution and Public Availability of PMA Summary of Safety and Effectiveness Data Packages (10/10/1997) |
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| Draft Guidance for Industry and FDA Staff - Modifications to Devices Subject to Premarket Approval (PMA) - The PMA Supplement Decision-Making Process (03/09/2007) |
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| Draft Guidance: Likelihood of Facilities Inspections When Modifying Devices Subject to Premarket Approval (08/05/1999) |
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| Early Collaboration Meetings Under the FDA Modernization Act (FDAMA) (2/19/98 (P98-3) (02/19/1998) |
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| Expedited Review of Premarket Submissions for Devices - Guidance for Industry and FDA Staff (02/29/2008) |
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| FDA and Industry Actions on Premarket Approval Applications (PMAs): Effect on FDA Review Clock and Performance Assessment - Guidance for Industry and FDA Staff (06/30/2008) |
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| Guidance Document for the Preparation of IDE and PMA Applications for Intra-Articular Prothetic Knee Ligament Devices (02/18/1993) |
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| Guidance for Industry and FDA Staff - Statistical Guidance on Reporting Results from Studies Evaluating Diagnostic Tests (03/13/2007) |
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| Guidance on PMA Interactive Procedures for Day-100 Meetings and Subsequent Deficiencies (2/19/1998) (P98-2) (02/19/1998) |
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| Guidance on PMA Interactive Procedures for Day-100 Meetings and Subsequent Deficiencies - for Use by CDRH and Industry; Final (02/19/1998) |
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| Guidance on Section 216 of the Food and Drug Administration Modernization Act of 1997 (08/09/2000) |
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| Guidance to Industry Supplements to Approved Applications for Class III Medical Devices: Use of Published Literature, Use of Previously Submitted Materials, and Priority Review; Final (05/20/1998) |
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| In Vitro Diagnostic Model for a Pilot for Streamlined PMA Review |
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| Letter to IVD Manufacturers on Streamlined PMA; Final (12/22/1997) |
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| Panel Report and Recommendations on PMA Approvals #P86-5 (blue book memo) (04/18/1986) |
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| Panel Review of Premarket Approval Applications #P91-2 (blue book memo) (05/03/1991) |
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| PMA Compliance Program #P91-3 (blue book memo) (05/03/1991) |
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| PMA Post Approval Studies (04/06/2007) |
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| PMA Review Statistical Checklist |
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| Premarket Approval Application (PMA) Closure #P94-2 (blue book memo) (07/08/1994) |
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| Premarket Approval Application Content Shell |
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| Premarket Approval Application Filing Review - Guidance for Industry and FDA Staff (05/01/2003) |
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| Premarket Approval Application Modular Review - Guidance for Industry and FDA Staff (11/03/2003) |
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| Premarket Approval Applications (PMA) for Sharps Needle Destruction Devices; Final Guidance for Industry and FDA (03/02/2001) |
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| Premarket Assessment of Pediatric Medical Devices - Guidance for Industry and FDA Staff (05/14/2004) |
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| Quality System Information for Certain Premarket Application Reviews; Guidance for Industry and FDA Staff (02/03/2003) |
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| Real-Time Premarket Approval Application (PMA) Supplements - Guidance for Industry and FDA Staff (04/28/2006) |
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| The Least Burdensome Provisions of the FDA Modernization Act of 1997: Concept and Principles: Final Guidance for FDA and Industry (10/04/2002) |
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| Threshold Assessment of the Impact of Requirements for Submission of PMAs for 31 Medical Devices Marketed Prior to May 28, 1976 (01/01/1990) |
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| User Fees and Refunds for Premarket Approval Applications - Guidance for Industry and FDA Staff (11/24/2003) |
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