All terms
Annual Report (PMA)
Yearly report required for Class III PMA devices summarizing changes, complaints, and post-approval study status.
Reviewed by Christian Espinosa, Founder, Blue Goat CyberLast reviewed September 19, 2026
Definition
21 CFR 814.84 requires PMA holders to submit annual reports within 60 days of the PMA approval anniversary, summarizing unreported changes, adverse reaction summaries, and progress on post-approval study commitments. Annual reports cover changes made under the 'reported in annual report' route of 21 CFR 814.39(b), summaries of literature and unpublished reports on the device, and any adverse experience data not already reported under Part 803. PMA conditions of approval may require additional content. Changes that affect safety or effectiveness need a PMA supplement instead and cannot wait for the annual report. What the regulation says
The FDA, under 21 CFR 814.84, mandates that holders of Premarket Approvals (PMAs) submit annual reports. These reports are crucial for ongoing regulatory oversight, ensuring devices remain safe and effective post-market. They summarize changes not previously reported, provide adverse event data, and update on post-approval study progress, as specified in the PMA approval order.What this means in practice
Late or incomplete PMA Annual Reports trigger Warning Letters and can affect approval status.Examples
- A manufacturer of an implantable cardiac device includes a summary of minor material supplier changes not requiring a PMA supplement in their annual report.
- A company developing a new diagnostic imaging system details the enrollment progress for their post-market clinical follow-up study as part of their annual submission.
- An adverse event summary in the annual report highlights a trend of a specific device malfunction, leading the FDA to request further investigation.
Common pitfalls
- •Failing to submit the annual report within 60 days of the PMA anniversary can lead to regulatory action, including Warning Letters.
- •Incomplete annual reports, especially those lacking required summaries of changes or adverse events, are a common pitfall.
- •Overlooking the summarization of progress on post-approval study commitments can render the report deficient.
- •Assuming no changes or adverse events means no report is necessary is incorrect, as a report confirming this is still required.
- •Not maintaining thorough documentation throughout the year to easily compile the annual report can result in last-minute rushes and errors.
Frequently asked questions
The primary purpose is to provide the FDA with an annual summary of any unreported changes, adverse reactions, and the progress of post-approval studies, ensuring continued compliance and device safety.
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Sources
3 sourcesSources support the definition or relevant regulatory context, not necessarily every claim on this page. Each is graded against our source-tier hierarchy so you can see what rests on binding law versus commentary.
Tier 1Binding law and standards· 1Tier 2Regulator guidance and consensus· 2
Link health: 3 verified· last checked 2026-06-20
eCFR·1FDA·1European Commission·1
- 121 CFR 814.84Tier 1 VerifiedeCFRecfr.gov
- 2FDA Recalls - Medical DevicesTier 2 VerifiedFDAfda.gov
- 3EUDAMED Public SiteTier 2 VerifiedEuropean Commissionec.europa.eu
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