Dear Erion,
Guidance
Annual Reports for Approved Premarket Approval Applications (PMA) contains description of the types of changes required in the PMA annual report. Basically, any change that does not affect the device's safety or effectiveness can be implemented without a supplement a submitted in the PMA annual report. Per 21 CFR 814.84, the annual report of an approved PMA should contain the following information. The requirements and the corresponding information supplied in the subject report are noted below:
1. Changes already reported via a supplement as per 21 CFR 814.39(a)
2. Changes not previously reported under a supplement because the PMA applicant deemed them to be reportable under an annual report as per 21 CFR 814.39(b)
3. Summary and bibliography of unpublished reports and published literature under 21 CFR 814.84(b)(2)
4. Devices sold and distributed
5. MDR Review
6. Unique Device Identifier (UDI) per 21 CFR 814.84(b)(4)
7. Any additional reporting requirements specified to the device and / or approval order.
Refer to 21 CFR 814.39 for changes reported in the PMA Annual Report, but require a PMA Supplement or multiple PMA supplements, with or without additional deficiencies with the 21 CFR 814.82 and 21 CFR 814.84 elements.
I hope this helps.
Thank you,
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Juliane Carvalho RAC, MSc
Lead Regulatory Health Project Manager
United States
**My comments are an informal communication and represent my own best judgement. These comments do not bind or obligate the U.S. Food and Drug Administration**
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Original Message:
Sent: 20-Apr-2022 10:28
From: Erion Kallushi
Subject: PMA Supplement vs Annual Report
Good day,
Does anyone have a comprehensive list/table of changes that require submission of a PMA supplement vs an Annual Report?
I did find some good info on the "Modifications to Devices Subject to PMA - The PMA Supplement Decision Making Process" guidance, but wanted to reach out if anyone has something else that better defines examples of different changes and whether is appropriate to submit a supplement or an annual report.
Thank you!
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Erion Kallushi
Regulatory Affairs Specialist
Marlborough MA
United States
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