A significant decision carries its own clock

A Not Substantially Equivalent letter, a PMA denial, an IDE disapproval, a refused Breakthrough Designation request — each one reads like an ending. The instinct that follows is usually informal: a call to the reviewer, a resubmission, a Q-Sub asking what would change the outcome next time. FDA built a formal answer to exactly this moment, with its own name and its own clock, and it is easy to spend a career at a device company without ever needing to open it.

A statute for one specific kind of decision

Section 517A of the FD&C Act, at 21 U.S.C. § 360g-1, requires CDRH to document the scientific and regulatory rationale behind a defined list of significant decisions — a 510(k)’s Not Substantially Equivalent or Substantially Equivalent call, a PMA or HDE approval or denial, a Breakthrough Device Designation determination, an IDE approval or disapproval, and a few narrower calls under Section 520(g). FDA’s implementing regulation, 21 CFR 800.75, turns that documentation requirement into an actual appeal path: a sponsor can request supervisory review of the decision, and, on request, ask FDA to convene a Dispute Resolution Panel to look at it independently.

Thirty days, not sixty, and the clock starts at the decision

FDA’s general internal-review rule, 21 CFR 10.75, gives a requester 60 days to ask for supervisory review of an ordinary agency decision. Section 517A significant decisions don’t get that long: 800.75 sets the deadline at 30 days from the date of the decision itself — not from the date a sponsor received the letter, read it, or convened internally to decide how to respond. A firm that spends three weeks assembling an internal position before deciding whether to appeal can lose the option to appeal at all, on a clock that was already running before that meeting was scheduled. The CDRH Ombudsman can explain the process and sit in as an observer, particularly when a sponsor believes its situation is unusual enough to raise directly — but the Ombudsman doesn’t decide the appeal, and doesn’t extend the deadline.

A Q-Sub asks FDA to reconsider before a decision exists. A 517A appeal asks it to reconsider one that already does — on a thirty-day clock most sponsors never look up until the letter that starts it is already sitting in their inbox.

An overturned decision leaves no mark of its own

Win a 517A appeal on an NSE letter and the eventual clearance, if one follows, posts to openFDA’s 510(k) record exactly the way any other clearance does — the same SESE or SESU code, the same fields, no flag anywhere marking that the file reached that decision on its second pass through a formal review rather than its first. A product-code history read from the public record alone cannot tell an appeal apart from an uneventful clearance; the difference lives only in the sponsor’s own file.

The practice

Reading the decision letter’s date the day it arrives, before drafting any response at all, is the difference between having a live appeal option and finding out later that the calendar closed it. FDA Radar’s own sources don’t reach this process at all — per what we monitor and how often, none of its five feeds touches an internal-agency-review request, because nothing about a 517A appeal is required to become a public record. Whether a specific decision is worth appealing, and what to say in the request, is a judgment for the regulatory professionals and counsel who own that file — this describes how the path works, regulatory intelligence and method, never a recommendation about any submission.