Regulatory Services
FDA requires every foreign device manufacturer that exports devices to the United States to designate a US Agent — a US-based representative who serves as the primary FDA communication channel for the manufacturer. Without a properly designated US Agent, a foreign manufacturer cannot complete FDA registration and their devices cannot legally enter US commerce.
Designate Your US AgentUS Agent Requirements
Under 21 CFR 807.40, foreign device establishments that are required to register with FDA must designate a US Agent. The US Agent must be a US resident or have a place of business in the United States, must agree to serve as the agent, and must be available to FDA during normal business hours. The US Agent's name, address, telephone number, and email address must be listed in FDA's device establishment registration database (FURLS/CDRH Device Registration and Listing Module).
FDA uses the US Agent as the primary point of contact for the foreign establishment for all purposes — 510(k) correspondence, inspection notices, import detention communications, warning letters, and other regulatory actions directed at the foreign manufacturer route through the US Agent. A US Agent that is not responsive, does not understand the manufacturer's regulatory situation, or does not forward FDA communications promptly creates significant compliance risk for the foreign manufacturer. We serve as US Agent with active regulatory expertise — not just a name and address in the FDA database.
FDA device establishment registration must be renewed annually during the October 1 through December 31 registration renewal period. Establishments that fail to renew registration by the deadline face suspension of their FDA registration, which means their devices become subject to refusal of admission at US ports of entry. The registration renewal process requires updating the establishment information, listing all devices by 21 CFR Part 880-890 product code, and confirming the US Agent designation.
Device listing updates — which must be submitted when devices are added or removed from commercial distribution — are due within 30 days of the change. Keeping device listings current is an ongoing obligation separate from annual registration renewal. We manage the full registration and listing calendar for our US Agent clients, including reminders and submission support for all FDA registration and listing requirements throughout the year.
When FDA sends a communication to a foreign manufacturer — whether it is an Additional Information request during a 510(k) review, a detention notice for an import entry, a notice of FDA inspection, or a Warning Letter — that communication must be received, understood, and acted upon promptly. US Agents who simply forward communications without analysis or context provide limited value. We receive FDA communications, analyze them in the context of the manufacturer's regulatory situation, advise on response strategy, and coordinate the response with the manufacturer — providing the active regulatory representation that the US Agent role is intended to enable.
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US Agent designation is a legal requirement, but the value of the role is in the regulatory expertise behind it. We serve as US Agent with the regulatory knowledge to represent your interests with FDA effectively.