Post-Market
Annual Report (PMA)
In one line
Yearly report required for Class III PMA devices summarizing changes, complaints, and post-approval study status.
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reports cover changes made under the 'reported in annual report' route of 21 CFR 814.39(b), summaries of literature and unpublished reports on the device, and any adverse experience data not already reported under Part 803.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.
Why it matters
Late or incomplete PMA Annual Reports trigger Warning Letters and can affect approval status.
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.
Sources
- 21 CFR 814.84 · eCFR
- FDA Recalls - Medical Devices · FDA
- EUDAMED Public Site · European Commission