Medical Device U.S. Agent Services

A U.S. Agent is a U.S.-based person or entity designated by a foreign medical device establishment subject to FDA registration requirements. The agent must reside in the United States or maintain a place of business in the United States and must have a physical location where FDA can reach the agent; a P.O. box, mail drop, or answering service alone is not sufficient.

Foreign medical device establishments subject to 21 CFR Part 807 registration requirements must identify a U.S. Agent as part of their establishment registration. This includes applicable foreign manufacturers and other foreign establishments whose activities require registration when devices are imported or offered for import into the United States.

FDA describes four core responsibilities: assisting FDA communications with the foreign establishment; responding to questions about devices imported or offered for import into the United States; assisting FDA in scheduling inspections of the foreign establishment; and receiving information or documents from FDA when FDA cannot contact the foreign establishment directly or expeditiously.

No. FDA states that each foreign medical device establishment may designate only one U.S. Agent. The establishment may also designate that same person or entity as its official correspondent, but doing so is optional.

Yes. FDA sends an electronic verification request to the U.S. Agent. The agent must confirm consent to act for the foreign establishment. If the agent denies the designation or does not respond within 10 business days, FDA notifies the establishment and a new U.S. Agent must be designated to satisfy the registration obligation.

No. The roles are distinct. A foreign establishment may choose to designate its U.S. Agent as its official correspondent, but FDA does not require the two roles to be held by the same person or entity.

No. A U.S. Agent is a regulatory liaison for FDA communications. The role does not make the agent the importer of record, customs broker, initial importer, distributor, or commercial representative unless a separate agreement establishes one of those roles.

No. FDA specifically notes that the U.S. Agent has no responsibility for adverse-event reporting under 21 CFR Part 803 or for submitting 510(k) Premarket Notifications under 21 CFR Part 807, Subpart E. Those obligations remain with the appropriate responsible parties.

FDA Registration Assistance charges $849 per year for Medical Device U.S. Agent service. This is our professional service fee for maintaining the designation, managing FDA communications within the U.S. Agent role, supporting inspection scheduling, and coordinating annual agent-information review. It is separate from any FDA establishment registration user fee that may apply.

No. The U.S. Agent requirement applies to foreign establishments that are subject to the applicable FDA device registration requirements. A domestic U.S. establishment is already located in the United States and does not designate a U.S. Agent for that domestic establishment.

Yes, if the person meets FDA's U.S.-presence requirements. The individual must reside in the United States or maintain a place of business in the United States, have a physical location that FDA can visit, and be reachable during normal business hours. A mail drop or answering service alone is not acceptable.

Yes. The foreign establishment can update its registration information in FURLS/DRLM to identify a new U.S. Agent. The newly designated agent must then complete FDA's confirmation process. We can coordinate the change so the registration record is updated accurately.

Yes. Foreign establishments review and verify their registration information annually, including U.S. Agent information. Device establishment registration information is generally reviewed during the annual October 1 through December 31 registration period. Our professional U.S. Agent service is billed annually at $849 per year.

FDA requests the U.S. Agent's name, U.S. address, telephone number, fax number if applicable, and email address as part of the foreign establishment's registration information. We provide the required agent details and coordinate the electronic confirmation of the designation.

Yes. FDA's rules do not limit a qualified U.S. Agent to representing only one foreign establishment. The agent must still be able to satisfy FDA's communication and availability requirements for every establishment represented.

Submit your foreign establishment name, physical address, owner or operator details, and any existing FDA registration information through the form on this page. We will provide the U.S. Agent details needed for your registration, coordinate the FDA confirmation request, and begin annual representation once the engagement is finalized.