A 522 order is FDA's ask, not the sponsor's own plan

A file that already tracks an MDR post-market surveillance plan or a PMCF plan a manufacturer wrote and filed on its own initiative can start to treat every post-market surveillance obligation as one shape: a plan the firm designs, on a timetable the firm sets, that a regulator later reviews. Section 522 of the FD&C Act, implemented at 21 CFR Part 822, doesn't work that way. It gives FDA the authority to order a specific class II or class III device to undergo postmarket surveillance — on FDA's own initiative, against FDA's own criteria, on a clock FDA starts. A tracker that logs a 522 order the same way it logs a voluntary PMS filing has missed which party actually opened the file.

An order, not an invitation

21 CFR 822.1 states the authority directly: FDA may by order require a manufacturer to conduct postmarket surveillance of a class II or class III device. The order isn't a response to something the manufacturer proposed, and it isn't optional once issued — it's a direct exercise of FDA's own statutory authority, arriving as a document naming a specific device and requiring a specific response. A regulatory affairs team's first job on receiving one isn't to decide whether to comply; it's to read the order's own scope and deadlines correctly.

A fixed list decides which devices qualify

FDA doesn't order 522 surveillance on any device it has a general interest in watching. Part 822 limits the authority to devices meeting at least one of four named criteria: failure of the device would be reasonably likely to have serious adverse health consequences; the device is intended to be implanted in the human body for more than one year; the device is intended to be used outside a user facility to support or sustain life; or the device is expected to have significant use in pediatric populations. A device that doesn't meet any of the four criteria isn't a candidate for a 522 order at all, whatever else its risk profile looks like on paper.

Thirty days to plan, fifteen months to start

Once an order issues, 21 CFR 822.9 and 822.10 set out what the manufacturer's own postmarket surveillance submission has to contain, but the clock runs independently of that content: the manufacturer has to submit a surveillance plan within 30 days of receiving the order, and has to commence the surveillance itself no later than 15 months after the date FDA issued the order. FDA then reviews the submitted plan and responds within 60 days. None of these three deadlines is a target either side aims for loosely — they're the dates the regulation itself sets, running from the order, not from whenever the manufacturer gets around to drafting a response.

Disagreement has its own procedure, not a default extension

A manufacturer that disagrees with FDA's view of what the plan should contain, or whose submitted plan FDA disapproves, doesn't get to simply keep operating under its own preferred version while the dispute sits open. 21 CFR 822.22 sets out the recourse available at that point, a defined process rather than an informal negotiation the file can treat as pending indefinitely. A tracker that logs “plan submitted” as the last meaningful status on a 522 order has stopped tracking a step earlier than the regulation actually closes the file.

Where this meets the file

A postmarket surveillance tracker built to hold both instruments has to keep them on separate rows: the ongoing reporting duties every device carries under Part 803 and a voluntary PMS or PMCF file a manufacturer designs on its own belong on one track; a 522 order — its criteria, its 30-day and 15-month deadlines, and FDA's own 60-day response window — belongs on a different one entirely, because only one of the two tracks starts with FDA's own signature on the order. A 522-order worksheet built around Part 822's own deadlines is previewed in the launch catalog. If your program handles this differently, the shelf takes that correction directly.