Registered. Not reviewed.

A device’s entry in FDA’s establishment registration and listing database can carry a 510(k) number, a PMA number, or a De Novo number right there in the record. It reads like confirmation — FDA has this device, FDA cleared it this way. What’s actually in that field is whatever the owner or operator typed into the form, once a year, and FDA’s own rule says the registration process that field lives inside does not check it.

What Part 807 actually asks for

21 CFR Part 807requires every device manufacturer and initial importer to register its establishment and list its devices with FDA, renewed every year in the same window — October 1 through December 31. 21 CFR 807.25spells out what the listing has to include, and for a device that needs marketing authorization before sale, that’s a premarket submission number: a 510(k), De Novo, PMA, PDP, or HDE number, supplied by the owner or operator itself. Nothing in Part 807 has FDA cross-check that number against its own clearance or approval records at the moment the listing is filed. The listing process is a filing requirement, not a review.

The rule that says so, in FDA’s own words

FDA doesn’t leave this to inference. 21 CFR 807.39, titled Misbranding by reference to establishment registration or to registration number, states plainly that registering an establishment or holding a registration number does not in any way denote approvalof the establishment or its products, and that any representation creating the impression of official approval because of registration is misleading and constitutes misbranding. The rule exists because the confusion it corrects is common enough to need its own section — a registration number looks exactly like the kind of thing an agency issues after checking something.

What a listing record is actually good for

None of this makes the registration and listing database useless — it is often the fastest public confirmation that a given firm makes a given device at all, and which product code and regulation number the firm itself associates with it. It is a lead, not a verified fact. The premarket number in a listing is exactly as current as the last annual filing, entered by the company describing its own device, and a lookup that treats it as equivalent to the decision record in FDA’s 510(k) or PMA database is trusting a self-report where a primary source exists a search away.

The practice

Treat a premarket number found in a registration and listing record as a pointer, not a citation. Confirm it against FDA’s own clearance or approval database before it goes into a predicate list, a competitive teardown, or anything else that will be read as fact. That one extra lookup is the difference between citing FDA and citing what a company told FDA about itself — regulatory intelligence and method, never regulatory advice, and the distinction matters most exactly where the two records might disagree.