FDA Establishment Registration and Device Listing: Step-by-Step Guide

Who Must Register and List with FDA

FDA establishment registration and device listing requirements under 21 CFR Part 807 apply broadly to organizations involved in the manufacture, preparation, propagation, compounding, assembly, or processing of medical devices intended for US commercial distribution. This includes original equipment manufacturers (OEMs), contract manufacturers, contract sterilizers, repackagers, relabelers, and importers of foreign-manufactured devices.

Foreign manufacturers who export devices to the United States must also register with FDA and designate a US agent. The US agent must be physically located in the United States, must accept correspondence from FDA on behalf of the foreign manufacturer, and must be available to assist FDA with translations, inspections, and regulatory communications.

Registration and listing are distinct obligations. Registration identifies the establishment (the physical location where device manufacturing activities occur). Listing identifies the specific devices manufactured at or imported through that establishment. Both are required — a registered establishment without current device listings is non-compliant, and device listings without establishment registration are non-compliant.

Certain establishments are exempt from registration and listing requirements. Retail establishments that sell devices to end users, licensed practitioners who manufacture devices for use in their own practice, and certain nonprofit blood banks are among the exempted categories. However, if you are uncertain whether your establishment qualifies for an exemption, the safe course is to register — late registration is better than discovering during an FDA inspection that you were required to register and did not.

Annual Registration: Timeline and Process

FDA establishment registration must be renewed annually. The annual registration period runs from October 1 through December 31 each year, for the following fiscal year. Establishments that fail to renew their registration by December 31 are considered unregistered for the following year, and their devices cannot be legally imported into or distributed in the United States until registration is renewed.

FDA registration is completed electronically through the Unified Registration and Listing System (FURLS), accessible at FDA.gov. To register, you must have an active FDA Account (username and password), a Data Universal Numbering System (DUNS) number for your establishment, and your establishment's physical address and contact information.

Registration fees: FDA charges an annual registration fee, which is updated annually by FDA. The current fee schedule is published on FDA.gov. Payment must be made at the time of initial registration and at each annual renewal. Establishments that fail to pay the applicable registration fee are non-compliant regardless of whether they complete the online registration form.

Foreign establishments: Foreign manufacturers must register using their US agent's contact information as the primary FDA contact. The US agent must have a physical US address (not a PO Box). If your US agent changes during the year, you must notify FDA within 30 days and update your FURLS registration.

Post-registration confirmation: After completing registration, FURLS generates a registration number and a registration confirmation that should be retained as part of your regulatory records. FDA's registration database is publicly searchable — verify that your establishment and device listings appear correctly after submission.

Device Listing: What Devices Must Be Listed

Every device commercially distributed in the United States must be listed with FDA by the manufacturer or importer. Device listing must be completed at initial registration and must be updated within 30 days of any change to the listed information, including introduction of new devices, discontinuation of devices, or material changes to device information.

Device listing information includes: the proprietary device name and any established name, the device classification (product code and 21 CFR Part applicable), whether the device is Class I (exempt or requiring 510(k)), Class II, or Class III, and the premarket submission number (510(k) number, De Novo number, or PMA number) if applicable.

Product codes: FDA assigns a three-letter product code to each type of device, which maps to the device's classification regulation in 21 CFR. Selecting the correct product code is critical because it determines the regulatory requirements applicable to your device. FDA's Product Classification Database is the authoritative source for product codes — search by device type, intended use, or material to identify the applicable code.

Premarket exemptions: Many Class I and some Class II devices are exempt from premarket notification (510(k)) requirements. A 510(k)-exempt device can be listed without a premarket submission number. However, being 510(k)-exempt does not mean QSR/QMSR-exempt — exempt Class I devices still must comply with applicable quality system requirements (with some exceptions for devices exempt from QSR as well).

UDI integration: Since FDA's UDI rule came into effect, device listings in FURLS must include the device's Unique Device Identifier (UDI) information, specifically the device identifier (DI) portion of the UDI. UDI-DIs must be submitted to FDA's Global Unique Device Identification Database (GUDID) before they can be included in FURLS device listings.

Common Mistakes That Create Registration and Listing Problems

Registration and listing errors are surprisingly common, and they can create significant regulatory problems — particularly for import of foreign-manufactured devices, where FDA can refuse admission to shipments from unregistered establishments.

Missed annual renewal: The most common and serious error is missing the October-December renewal window. FDA does not send renewal reminders. It is the manufacturer's responsibility to initiate renewal. Set a recurring calendar reminder for October 1 every year. If you miss the renewal window and your registration lapses, your devices cannot be legally imported or distributed in the US until you renew and pay applicable fees.

Incorrect product codes: Using the wrong product code affects the regulatory requirements that apply to your device listing. An error in product code can result in being listed under a classification that requires a 510(k) when your device is actually exempt, or vice versa. Review your product code assignment against the FDA Product Classification Database annually.

Failing to update device listings for new products: Introducing a new device to the US market without updating your device listing (within 30 days) is a violation of 21 CFR Part 807. Before commercial distribution of any new device, confirm that the device is listed with FDA.

Outdated US agent information: For foreign manufacturers, outdated US agent information means FDA cannot reach you for communications, import inquiries, or inspection notice. If your US agent changes, update FURLS within 30 days.