Regulatory Services
Ranking, researching, and re-reading FDA guidance won't get your device to market — registration and listing will. We handle establishment registration, device listing, and product code assignment as a flat-fee service, so your device is legally marketable without you touching FURLS.
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. Our FDA establishment registration requirements guide outlines the full process and flat-fee service options.
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 formal 513(g) classification request to FDA 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.
FDA establishment registration must be renewed every year during the October 1 through December 31 renewal window. Missing this deadline causes the registration to lapse automatically — FDA does not send individual reminders, and the FURLS system updates the establishment's status to "expired" on January 1. Once registration expires, any device listed to that establishment is subject to refusal of admission at US ports of entry until the establishment renews and pays the current-year user fee.
Device listings must similarly be kept current throughout the year. Listings must be updated within 30 days of introducing a new device, discontinuing a listed device, or making a change that affects the product code or regulatory class. Manufacturers who fail to update listings within this 30-day window are subject to import detention for the affected device models — a consequence that can halt distribution for weeks while FDA clears the discrepancy.
No. Registration under 21 CFR Part 807 is an administrative requirement identifying your facility as a medical device manufacturer. It is not FDA approval or clearance of your product. Devices still require any required pre-market submission (510(k), De Novo, or PMA) independently.
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.
Yes. Foreign establishments must designate a US Agent who maintains a US presence and serves as FDA's point of contact. The US Agent must be named during establishment registration and is responsible for forwarding FDA communications to the foreign facility.
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.