Registration and listing are two different FDA duties

It's common to hear “we're registered with FDA” used as shorthand for a device being cleared to market, and just as common to see a compliance calendar carry one line item for the two obligations 21 CFR Part 807 actually keeps separate. Registration attaches to the establishment doing the work. Listing attaches to the device itself. A firm can be fully registered and still be missing a required listing, or vice versa, and neither filing is the premarket decision this blog has already covered under Acceptance Review or 807.81(a)(3). Part 807 runs on its own logic, and a record that conflates the three is tracking one obligation where three actually exist.

Who has to register isn't limited to manufacturers

21 CFR 807.20 names who the registration and listing requirement reaches, and the list runs wider than the word “manufacturer” suggests: anyone who initiates or develops specifications for a device to be manufactured by a second party, anyone who sterilizes or otherwise makes a device on behalf of a specifications developer or other person, anyone who repackages or relabels a device, anyone who reprocesses a single-use device previously used on a patient, and any initial importer. A firm that sends product out to a contract sterilizer or repackager and assumes registration is the sterilizer's problem alone is reading a narrower rule than 807.20 actually sets — the section reaches the activity, not just the party holding the marketing authorization. It carves out one clear exception: a wholesale distributor that doesn't manufacture, repackage, process, or relabel a device doesn't fall under 807.20 at all.

Two filings, not one, and two different subjects

Registration, governed by 807.21 and 807.25, is about the establishment: its name and address, the owner or operator, an official correspondent, and the activities it performs. Listing is about the device: its trade name, its classification and applicable product code, and the establishment that performs each listed activity for it. An establishment registers once and updates that record as its own information changes; each device it handles gets its own listing entry layered on top. A compliance file that only tracks “are we registered” has answered the establishment question and left the device question, which 807.25 asks separately, entirely open.

An annual clock that runs independent of any submission

21 CFR 807.22 sets the recurring obligation: every establishment has to review and update its registration and listing information annually, during the period beginning October 1 and ending December 31. That window has nothing to do with when a 510(k) was cleared or a PMA approved — it runs every year, for every registered establishment, regardless of what premarket activity did or didn't happen that year. Separately, 807.21(b) requires any change to the registration information itself — a new address, a different official correspondent — to be reported within 30 days of the change, not held for the next annual window. A registration record updated only once a year, on the October filing, is missing the 30-day duty that runs on its own trigger.

What the filing explicitly does not mean

FDA states the limit on this directly: registration of a device establishment, or assignment of a registration number, does not in any way denote approval of the establishment or its products, and representing it otherwise is misleading. Listing carries the same limit — a device appearing in FDA's listing database is not itself a marketing authorization. The premarket question, whether a device needs a 510(k) at all and what class it falls into, is a separate determination this blog has already covered; registration and listing are the standing administrative record a firm keeps regardless of which premarket path, if any, a given device required.

Foreign establishments add a name to the file

Subpart C extends the same two obligations to foreign establishments under 807.40: any foreign facility manufacturing, preparing, or processing a device imported into the United States has to register and list using the same electronic system, and no device may be imported unless it's the subject of a listing and manufactured at a registered foreign establishment. A foreign-establishment file that stops at registration, without confirming every device actually crossing the border carries its own listing, has left the import gate half-checked.

Where this meets the rest of the file

A registration-and-listing tracker built around 807.20's actual reach, the establishment-versus-device split, and the annual and 30-day clocks 807.21 and 807.22 set is previewed in the launch catalog. If your program tracks these obligations differently, the shelf takes that correction directly.