Approved once. Reported every year.

A PMA approval is a single, dated event, and every public database agrees on when it happened. What that event starts is not single at all: 21 CFR 814.84 puts a report on the calendar every year afterward, for as long as the approval stands, whether or not anything else about the device ever changes. Nothing has to go wrong to trigger it. The clock itself is the trigger.

Automatic, not event-driven

A PMA supplement runs on its own clock, started by a change the holder chose to make. A postapproval study condition, written into the approval order under 21 CFR 814.82(a)(2), runs on a schedule FDA set at the moment of approval, for devices where FDA imposed one. The annual report owes neither of those preconditions. Every approved PMA gets one, due at intervals of one year counted from the date of the original approval, and the obligation exists purely because the approval exists — the one PMA filing that doesn’t wait for a reason.

What has to be in it

Section 814.84(b) isn’t a cover letter. Unless FDA has specified otherwise for a given PMA, the report has to identify the kinds of design, labeling, and manufacturing changes described elsewhere in Part 814 — the same categories a supplement would cover, reported here because they didn’t rise to the level a supplement requires. It has to carry a summary and bibliography of information bearing on the device’s safety or effectiveness that FDA hasn’t already seen. And, separately from both, it has to state how many devices were sold and distributed during the reporting period, broken out by model where the PMA covers more than one. None of that is optional boilerplate; it is the content the regulation names.

Adjacent to two other duties, identical to neither

The annual report sits next to, and is routinely confused with, two other obligations that look similar from a distance. It is not the Medical Device Reporting duty under Part 803 — a malfunction gets reported under 803 on its own timeline, and the annual report’s job is to confirm that duty was met, not to restate each report inside it. And it is not the postapproval study report this blog has covered before: a study condition is set once, for a specific PMA, and tracked in FDA’s own Post-Approval Studies database with its own status field. The annual report has no comparable database. It is owed by every approved PMA holder, every year, without exception for devices that were never given a study condition at all.

Nothing in public shows whether it happened

Here is the gap that makes this a practice note rather than a historical curiosity: FDA’s own PMA database carries the approval date and every supplement number that followed it, and the Post-Approval Studies database carries a status for an imposed study. Neither carries a field for “annual report, filed, this year.” The only record that a given year’s report exists is the correspondence between the holder and FDA. A subscriber, a competitor, or an acquirer reading the public record for a PMA has no way to confirm compliance with 814.84 from the outside, in either direction — and the holder has no public database to check against its own calendar, either.

The practice, stated plainly

The annual report belongs on a compliance calendar keyed to each PMA’s own approval date, not to the fiscal year or to any event a database would show changing. Treating it as something that will surface later, the way a supplement or an inspection would, mistakes a self-reported obligation for one FDA’s own records will flag. The regulation is explicit about what’s at stake in getting this wrong: failure to comply with any postapproval requirement, annual report included, is itself a basis for withdrawing the approval — a consequence that reaches the PMA’s standing directly, not just its paperwork.

Whether a specific PMA’s reporting history is complete, and what gap in it would actually concern a reviewer, is regulatory intelligence and method, never regulatory advice — a judgment for the holder’s own regulatory team. FDA Radar doesn’t carry a PMA source today at all — its feeds are the Federal Register, CDRH warning letters, and openFDA’s 510(k), enforcement, and classification APIs — and 814.84 compliance wouldn’t change that: there is no public feed anywhere for it to read.