An address is not a footprint

Every clearance in the openFDA 510(k) feed carries an applicant, a city, a state, a country code. It reads like a manufacturing address, and since FDA changed how the database populates that field, in August 2014, it reliably names the manufacturer of record rather than a consultant or third party filing on its behalf. What it has never been, on either side of that change, is the address of the place the device is actually made.

One field, a mailing address

FDA’s own file layout for the releasable 510(k) database describes what the applicant address actually is: a correspondence address — street, city, state, country, postal code — for the company of record on the submission. FDA Radar’s own ingestion keeps the same shape; the adapter that reads openFDA’s 510(k) endpoint stores state and country_code alongside the applicant name, and nothing more specific about location than that. A company headquartered in one state can manufacture in another, or through a contract facility overseas, and none of that shows up here — the field was built to say who to write to, not where the device came off a line.

A number the regulation requires and the record doesn’t carry

The submission itself has to say more. 21 CFR 807.87(b) requires every premarket notification to include the establishment registration number of the owner or operator submitting it — a number that identifies one specific, physically located place of business, not a mailing address. That number is filed. It is not one of the fields openFDA publishes back, and it is not one FDA Radar’s own 510(k) ingestion carries either — the interface the pipeline reads a clearance into has no place for it, because the public record it is built from has no place for it first.

The regulation asks a submission to name the place. The public record keeps the company and drops the place.

Where the place actually lives

It lives in a separate registration, under a separate part of the same regulation. 21 CFR Part 807, Subpart B requires every device establishment — defined, at 807.3, as one place of business under one management at one general physical location where a device is manufactured, assembled, or otherwise processed — to register separately, keyed to its own FDA Establishment Identifier. FDA’s Registration and Listing database holds that record, searchable by firm name or registration number. It is not joined to the 510(k) clearance record by any field either side publishes; nothing in one links to the other except a firm name a reader has to match by hand.

The practice

A supply-chain read on a portfolio — which of a firm’s devices actually depend on a given facility, foreign or domestic — cannot be answered from the clearance record alone, however completely it is read. It takes the separate registration and listing lookup, by firm name or registration number, to find the establishment a device actually runs through, and a clean applicant address on a 510(k) does not rule that step out. Whether a specific facility’s exposure — an import alert, an inspection finding, a foreign supplier’s own compliance history — changes anything for a specific product is a judgment for whoever owns that supplier relationship, on the facts of that relationship; this is a description of where the two records live and why they don’t meet, regulatory intelligence and method, never a determination about any firm’s own facilities.