A PMA stays approved only if the annual report arrives

A condition discharged one filing at a time

The annual report is where that periodic-reporting condition actually gets discharged, one filing at a time, for as long as the PMA stays on the market. 21 CFR 814.84(b) sets the underlying duty, but the obligation doesn't originate as a general regulatory habit; it's a specific condition of approval under 21 CFR 814.82(a), named in the approval order itself, that continued approval of the PMA is contingent on. A PMA holder who treats the annual report as a courtesy update, filed when convenient, has misread which side of the approval decision the filing actually sits on.

Annual unless the order says otherwise

The report's own timing isn't left to the holder's discretion. Unless FDA specifies a different interval in the approval order, a periodic report is due at intervals of one year from the date the original PMA was approved — not from the calendar year, not from the device's launch date, but from the approval itself. A supplement approval can reset or add its own reporting obligations on top of the original PMA's clock, which is why a device with a long supplement history can end up carrying more than one periodic-report due date running at once, each tied to a different approval order's own anniversary rather than to a single company-wide filing calendar.

Three things the report has to say, not a general update

The report's content isn't a free-form narrative of the year's activity. It has to identify changes described in 21 CFR 814.39(a) — the category of change that requires a PMA supplement — and separately identify changes reportable to FDA under 814.39(b), the category that can be reported in the periodic report itself rather than through a standalone submission. That's the same distinction this blog has already covered between a change that earns a full supplement and one that doesn't, and the annual report is where the second category actually gets filed, not just where it gets mentioned. Beyond the change accounting, the report has to carry a summary and bibliography of unpublished reports of data from clinical investigations or nonclinical laboratory studies involving the device or a related device, known or reasonably knowable to the applicant, plus the number of devices sold and distributed during the reporting period, broken out separately by model number where the device has more than one. A report that summarizes the year in general terms, without these specific, separately identifiable pieces, hasn't answered what 814.84(b) actually asks for.

Missing the deadline isn't a paperwork lapse

Because the annual report is a condition of approval rather than an administrative courtesy, FDA's own guidance treats continued approval of the PMA as contingent on the report actually being submitted. A holder that lets the report lapse hasn't just accumulated a compliance finding to clean up at the next inspection; it has failed a condition the approval itself was granted subject to, which is a materially different exposure than a late internal audit or an overdue training record. A PMA tracker that records the annual report as one line item among many post-approval housekeeping tasks, rather than as its own condition-of-approval field with its own due date tied to the approval order's anniversary, has filed the wrong kind of risk under the wrong kind of heading.

Where this meets the file

A PMA post-approval tracker needs the annual report's own due date calculated from the approval order's anniversary — not the calendar year, and not a single company-wide date when supplements have added their own reporting clocks — with the 814.39(a) and 814.39(b) change categories tracked as separate fields feeding it. A post-approval compliance tracker built around that structure, alongside this blog's own piece on what else an approval order's conditions can bind, is previewed in the launch catalog. If your program tracks the annual report differently, the shelf takes that correction directly.