FDA Annual Establishment Registration Renewal: What US Agents Must Do for Foreign Medical Device Manufacturers

The FDA Registration Renewal Window Is Not Optional — and Neither Is Your US Agent's Role

Every year, between October 1 and December 31, foreign medical device manufacturers must renew their FDA establishment registration for the upcoming fiscal year. Missing this window — or mishandling the US Agent responsibilities that come with it — can result in registration lapses, import alerts, and serious disruptions to US market access. For startup founders and regulatory teams managing lean operations, this is not a compliance checkbox. It is a business-critical obligation with real consequences.

This post breaks down exactly what US Agents are responsible for under 21 CFR Part 807, what foreign manufacturers need to confirm before the window closes, and where companies most commonly fall short.

The Regulatory Framework: What 21 CFR Part 807 Actually Requires

Under 21 CFR Part 807.40, every foreign establishment that manufactures, prepares, propagates, compounds, or processes a device for import into the United States must designate a US Agent. This is not a formality. The US Agent serves as FDA's primary point of contact for the foreign establishment and carries specific, enforceable responsibilities.

Per 21 CFR 807.40(b), the US Agent must:

• Assist FDA in communications with the foreign establishment
• Be physically located in the United States
• Be available during normal US business hours
• Be registered in FDA's Unified Registration and Listing System (FURLS) as the designated agent for that establishment

The annual registration renewal, conducted through the FURLS/Device Registration and Listing Module (DRLM), must be completed between October 1 and December 31 each calendar year, per 21 CFR 807.22. A registration that is not renewed within this window is considered lapsed — and a lapsed registration can trigger import refusal under Section 801(a) of the FD&C Act.

What US Agents Must Actually Do During the Renewal Window

This is where many foreign manufacturers and their regulatory teams underestimate the scope of the role. The US Agent is not simply a mailing address. During the annual renewal window, effective US Agents should be performing the following:

1. Confirm and Update Establishment Information

The US Agent must work with the foreign manufacturer to verify that all establishment data in FURLS is current — including the facility address, owner/operator information, and device listings. Any changes to manufacturing locations, device classifications, or product codes must be reflected at the time of renewal. Errors or outdated records flagged during an FDA inspection or import review can create significant regulatory risk.

2. Review Device Listings for Accuracy

Device listings under 21 CFR Part 807 Subpart D are tied directly to establishment registration. The renewal window is the appropriate time to audit whether all marketed devices are listed correctly, whether any discontinued products need to be removed, and whether new products introduced during the year have been listed as required. FDA's expectation is that listings reflect the current state of commercialized devices.

3. Serve as the Active Communication Bridge

During and after renewal, the US Agent must be reachable. If FDA attempts to contact the foreign establishment — whether for a pre-announcement inspection, an import inquiry, or a safety signal follow-up — the US Agent is the first call. Under 21 CFR 807.40(b)(2), the US Agent must forward communications from FDA to the foreign manufacturer and ensure responses are returned in a timely manner. An unresponsive or nominal US Agent creates liability for the manufacturer.

4. Coordinate Payment of the Annual Establishment Fee

Foreign establishments subject to the Medical Device User Fee Amendments (MDUFA) are required to pay an annual establishment registration fee. For FY2025, FDA set this fee at $7,653. The US Agent should ensure the manufacturer is aware of the fee obligation and that payment is completed within the renewal window. Unpaid fees result in an invalid registration, which directly impacts the ability to import devices into the US market.

Common Mistakes That Create Compliance Exposure

In our work with foreign manufacturers across Asia, Europe, and Latin America, we see these same issues arise during renewal season:

• Nominal US Agents with no regulatory expertise: Using a friend, a US subsidiary employee, or a logistics contact who has no working knowledge of 21 CFR Part 807 creates real risk. FDA expects substantive engagement, not a forwarding address.
• Stale device listings: Products launched mid-year that were never listed, or discontinued products that remain active in DRLM, are red flags during FDA audits and import reviews.
• Failure to update the US Agent record in FURLS: If a company changes its US Agent and does not update FURLS, FDA will continue attempting to contact the former agent. This can result in missed communications and a breakdown in compliance obligations.
• Assuming the manufacturer handles registration directly: Many foreign manufacturers believe their US importer or distributor manages registration. Unless that party is formally designated as the US Agent and the establishment owner/operator in FURLS, they have no authority or obligation to act in that capacity.

What Smart Regulatory Teams Do Before October 1

The companies that navigate the renewal window without incident treat preparation as a Q3 activity, not a December scramble. Before the window opens, your regulatory team should confirm that the designated US Agent has active FURLS access, that all device listings are reconciled with your current commercial portfolio, that any facility changes from the past year are documented and ready to update, and that the establishment registration fee has been budgeted and approved for payment.

If your US Agent cannot clearly answer questions about your device product codes, your 510(k) clearance numbers tied to listed devices, or the current status of your FURLS account, that is a signal worth acting on before October.

ADB Consulting and CRO Is Ready to Support Your Registration Compliance

At ADB Consulting and CRO Inc., we serve as US Agent and provide full establishment registration support for foreign medical device manufacturers navigating the FDA regulatory landscape. Andre Butler and our team bring direct experience with FURLS management, device listing audits, and FDA communications — so your registration is handled by people who understand what it actually means to your US market access.

Do not wait until December to discover a gap in your registration status. Book a free discovery call with our team today and let us assess your current registration posture before the renewal window opens. Visit adbccro.com to schedule your call.

For related guidance, see our annual registration renewal service.