The condition inside the approval order

An approved PMA is not always a finished transaction. 21 CFR 814.82(a)(2) lets FDA write a specific, named study into the approval order itself — a condition of that approval, set once, at the moment FDA grants it. The condition has its own legal basis, its own public database, and its own status vocabulary, and none of the three is the annual report every approved PMA owes automatically under a different section of the same part.

A condition, not a formality

21 CFR 814.82(a) lets FDA impose postapproval requirements in the PMA approval order or by regulation, and subsection (a)(2) names one specifically: continuing evaluation and periodic reporting on the safety, effectiveness, and reliability of the device for its intended use. When FDA uses it, the approval order itself states the reason for the requirement, the number of patients to be evaluated, and the reports the sponsor owes. This is not paperwork attached after the fact — it is written into the same order that grants the approval, and it applies only to the PMAs FDA decides need it, not to every approved device.

Not the annual report, and not a 522 order

Every approved PMA owes FDA a periodic report under 21 CFR 814.84, once a year unless FDA sets another interval, for as long as the approval stands — a universal, content-light continuation filing that exists regardless of any condition on the approval. A postapproval study under 814.82(a)(2) is narrower and more specific: a particular study, on a particular question, that FDA named as a term of that PMA’s own approval, and that the sponsor must actually execute, not merely file a status update against. It is also not a Section 522 order, which FDA can issue against any class II or III device meeting statutory criteria at any point in its life, whether or not the original approval — if the device needed one at all — carried a single condition. A 522 order asks a new question FDA did not have at approval. A postapproval study answers a question FDA already had before approval, and traded the approval for.

Its own database, its own vocabulary

FDA tracks required postapproval studies in a dedicated Post-Approval Studies (PAS) database, searchable by applicant or device, separate from the PMA lookup and from the 522 database that sits beside it in FDA’s own postmarket-requirements section. Every tracked study carries a status: Ongoing, proceeding on or ahead of schedule; Delayed, behind it; Terminated, ended before completion with no final report yet filed; or Submitted, completed or terminated with a final report in FDA’s hands. None of those four words appear anywhere in the PMA approval record itself — they exist only in the database FDA built specifically to hold them.

The approval record shows that FDA approved the device. A separate, purpose-built database — not the one anyone reads for the approval — is the only place that shows whether the condition FDA attached to that approval is actually being met.

The practice

Reading a Class III competitor’s approval off openFDA’s PMA record shows the approval and any later supplement. It does not show whether that approval carries a postapproval study condition, or whether the condition is on schedule — the PAS database is a separate FDA system this pipeline does not ingest, alongside PMA data generally, which sits outside what FDA Radar currently monitors. A Delayed or Terminated status against a competitor’s device is a fact worth having, and it says nothing on its own about whether the underlying safety question was ever resolved another way — reading that status correctly, for a specific device, is a judgment for a regulatory professional, not a conclusion this post draws for you. This is regulatory intelligence and method, never regulatory advice about any approval’s current standing.