Registration vs. Listing
FDA establishment registration and FDA device listing are two separate requirements under 21 CFR Part 807 — with two different renewal clocks, two different consequences for missing a deadline, and no exemption from pre-market clearance either way. Here's what each one actually requires, when each is due, and how ADB manages both under a single flat-fee engagement.
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FDA establishment registration and FDA device listing are related but separate requirements under 21 CFR Part 807. Registration identifies your facility as a device manufacturer, importer, repackager, or relabeler and requires an annual renewal. Listing records the individual devices your registered establishment distributes — by product code, device name, and regulatory class — and is updated on its own rolling schedule rather than once a year. Most manufacturers need to complete both, and most confusion in this area comes from treating them as a single step rather than two separate filings. If you need the registration itself — FURLS account setup, establishment submission, and the first device listed — see our device registration service.
Where establishment registration is a one-time (then annually renewed) filing about your facility, FDA device listing is the ongoing record of every device you distribute in the US — its product code, device name, and regulatory class — filed in FURLS under your registered establishment. It requires identifying each device by product code (21 CFR Part 880-892 classifications), providing the device name, the regulatory class, and the pre-market submission number (510(k), PMA, or De Novo) if applicable, or identifying the device as 510(k) exempt. Listings must be updated within 30 days of any change — adding a new product to commercial distribution, discontinuing a product, or making a significant change that would affect the product code or submission status.
Inaccurate or incomplete device listings create two types of risk. Regulatory risk: FDA import records and inspection databases reference device listing information — a device whose listing doesn't match the physical label or the pre-market submission creates discrepancies that investigators and import reviewers flag. Business risk: customers, distributors, and GPOs increasingly verify FDA registration status as a vendor qualification criterion — a suspended registration or a product that isn't listed prevents commercial relationships.
Correct product code selection is what makes a listing accurate — the code determines the device's regulatory class and whether it qualifies as 510(k) exempt. For devices that don't clearly fall into an existing product code, we file a 513(g) Request for Classification to get FDA's written determination before listing.
Establishment registration renews once a year, during the October 1 through December 31 window. FDA does not send reminders — if the window is missed, the registration lapses automatically, the FURLS system marks the establishment "expired" on January 1, and every device tied to that establishment becomes subject to refusal of admission at US ports of entry until the establishment renews and pays the current-year fee.
Device listing runs on a different clock entirely. Rather than a once-a-year window, listings must be updated within 30 days of any change — a new device entering distribution, a device being discontinued, or a change that affects the product code or submission status. Missing that 30-day window creates its own separate consequence: import detention for the specific device models affected, independent of whether the establishment's own registration is current.
FDA establishment registration confirms your facility is in FDA's database and identifies who is responsible for your devices. FDA device listing records the individual devices you distribute — by product code, name, and regulatory class — under that registered establishment. Registration renews annually (October 1–December 31); listing updates on a rolling basis, within 30 days of any change to what you distribute. Neither one substitutes for pre-market clearance or approval — a 510(k), De Novo, or PMA is still required independently where applicable.
Annual renewal is required between October 1 and December 31 each year. Registration that is not renewed lapses, which can trigger import detentions and distribution restrictions. We track the renewal window and submit on your behalf as part of every listing and registration engagement.
FDA device listing is required for all manufacturers, contract manufacturers, and repackagers of devices distributed in the US. You must list every device model with its product code and 510(k) number (if cleared).
Device listings must be updated during the FDA annual registration renewal window (October 1 – December 31) or within 30 days of introducing a new device or discontinuing a listed device.
Failure to list can result in your device being considered adulterated or misbranded, trigger import alerts, and potentially support a Warning Letter or injunction action.
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Registration and listing errors create import detentions and compliance findings. We manage FDA registration programs so your registration status is always current, accurate, and defensible.