Not every CDRH appeal runs on the same clock

A sponsor whose 510(k) comes back not substantially equivalent, or whose PMA is denied, usually has an appeal right the file has never had to use before — and the file's own language usually treats “appeal” as naming one process with one clock. It doesn't. This blog has already covered the completeness gate a submission passes through before FDA reads its substance, and an appeal sits on the far side of that same review: a decision has already been made, and the only question left is what happens next. 21 CFR 800.75, the regulation FDA finalized to govern supervisory review of CDRH decisions, splits that question into two tracks running two different clocks — and which track a disputed decision lands on depends on a fixed list Section 517A of the FD&C Act names by type, not on how the sponsor feels about the decision.

One rule, split into two tracks by what's being appealed

FDA finalized 21 CFR 800.75, “Requests for supervisory review of certain decisions made by the Center for Devices and Radiological Health,” in a rule issued July 2, 2019 and effective that August 1. A request for supervisory review of a CDRH decision has to comply with 800.75 alongside the FDA-wide provision at 21 CFR 10.75 that already covered supervisory review across the agency. What 800.75 actually does is split CDRH's own decisions into two buckets — the “significant decisions” Section 517A of the FD&C Act names, and every other decision a CDRH employee makes — and attach a different set of deadlines to each one. Both tracks still start the same way, with a request addressed to the immediate supervisor of the person who made the decision, but the clock running underneath that request depends entirely on which bucket the decision falls into.

517A names its own list, and nothing on it is a guess

Section 517A, added to the FD&C Act by the FDA Amendments Act of 2007, covers a fixed set of decision types: substantial equivalence determinations on a 510(k), PMA and HDE decisions, IDE decisions, Breakthrough Device designation requests, a sponsor and FDA failing to reach agreement on a study protocol under section 520(g)(7), and Clinical Hold determinations. A request for supervisory review of one of these has to reach CDRH within 30 days of the decision being appealed, and FDA owes an answer back on a matching schedule — within 30 days of a meeting or teleconference the sponsor requested, or within 45 days of the request itself if no meeting was asked for. Those aren't internal service targets FDA aspires to hit. They're deadlines the regulation sets on both sides of the exchange.

Everything else runs on a longer, softer clock

A CDRH decision that isn't on 517A's list still carries a supervisory-review right under 800.75 — the section covers decisions “other than 517A decisions” explicitly, not just the named ones — but the filing window stretches to 60 days instead of 30, and CDRH can accept a request filed later still, for good cause, where 517A's own 30-day window carries no equivalent grace. Nothing in 800.75 attaches the same fixed answer-by date to this track that 517A's list carries either. A tracker that logs a single column — “appeal filed” — for every disputed CDRH decision has erased the one distinction that decides how much certainty a sponsor is actually entitled to about when an answer comes back.

De Novo asked for the faster list and didn't get it

The clearest test of where the line actually sits is a request FDA turned down. When the agency finalized 800.75 in 2019, it declined to add De Novo classification requests to 517A's own named list of significant decisions, leaving a denied De Novo request to travel the slower, 60-day general track rather than the 30-day statutory one a denied PMA or a not-substantially-equivalent 510(k) gets. Two premarket routes that read as close siblings in a regulatory strategy memo — a 510(k) and a De Novo request both exist to establish a device's own path to market — carry genuinely different appeal rights once a decision comes back unfavorable, and a strategy file that assumes the two match on this point has assumed past the actual boundary 800.75 draws.

Where this meets the file

An appeal tracker built around this split needs the decision type recorded before anything else about the dispute itself — not just “PMA denied” or “510(k) NSE,” but whether that decision type actually appears on 517A's own list — because that single field decides whether the file is working against a 30-day filing deadline with a guaranteed 30-or-45-day answer, or a 60-day deadline with no matching promise from FDA's side. This blog has already covered the Q-Submission mechanism a sponsor uses to ask FDA a question before a decision exists; a supervisory-review request is a different instrument again, running after a decision exists rather than before one, and 517A is the only version of it the statute itself promises a date for. A CDRH-appeal worksheet built around the 517A list, the two filing windows, and FDA's own response deadlines is previewed in the launch catalog. If your program tracks this differently, the shelf takes that correction directly.