Regulatory Services
FDA device establishment registration and device listing are prerequisites for legally distributing medical devices in the United States. These requirements apply to manufacturers, initial distributors, and — for foreign manufacturers — are managed through the designated US Agent. Keeping registration and listing current is an ongoing obligation, not a one-time task.
Manage Your FDA RegistrationRegistration Requirements
Under 21 CFR Part 807, manufacturers of devices intended for commercial distribution in the United States, regardless of where they are manufactured, must register their establishment with FDA and list their devices. The requirement applies to manufacturers and initial importers; foreign manufacturers must register and designate a US Agent as part of registration. Distributors who do not alter the device are generally not required to register, but repackers and relabelers who change the labeling or packaging must register.
FDA device establishment registration is conducted through the FDA FURLS (Unified Registration and Listing System) portal. Initial registration requires creating an account, providing establishment information, paying the annual registration fee, and listing all devices manufactured or imported at the establishment. Registration must be renewed annually during the October 1 through December 31 renewal period. Establishments that miss the renewal deadline have their registration suspended, and their devices become subject to refusal of admission at US ports of entry until registration is reinstated.
Device listing 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.
Product code selection for device listing determines the device's assigned FDA classification (Class I, II, or III) and, critically, whether the device is 510(k) exempt. Many Class I and some Class II devices are 510(k) exempt, meaning they can be marketed without pre-market clearance. Identifying the correct product code for a novel device requires analysis of the 21 CFR classification regulations, FDA's product code database, and in some cases a 513(g) classification request for devices that don't clearly fall into an existing code. Selecting the wrong product code — particularly a code that incorrectly suggests 510(k) exemption — creates regulatory exposure when devices are imported or inspected.
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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.