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Essential FDA Resources & FAQs on U.S. Agent Requirements

U.S. Agent Resources and FAQs

Access FDA resources and FAQs on U.S. Agent requirements—who must appoint one, allowed roles, responsibilities, updates, and compliance rules. Learn how to maintain an effective U.S. Agent for smooth FDA interactions.

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Having the right information at hand can make managing U.S. Agent requirements much easier. Below are some authoritative resources and answers to frequently asked questions regarding U.S. Agents. 

Essential FDA Resources

  • FDA “U.S. Agents” webpage
    The FDA’s official Device Registration and Listing guidance includes a section on U.S. Agents, detailing the requirement, responsibilities, and limitations of the role. This is a primary reference for understanding FDA expectations.
  • 21 CFR 807.40 (Regulation text)
    Review summaries of cleared devices similar to yours. These summaries often include test methods and predicate comparisons that can inform your strategy. The Code of Federal Regulations section 807.40 is the legal rule that establishes the U.S. Agent requirement for foreign establishments. Reading the regulation text provides the exact language of the law (e.g., one agent per establishment, duties upon FDA request, 10-day update rule).
  • FDA Registration and Listing FAQs
    FDA’s online FAQ for device registration has specific Q&A for foreign establishments. Notably, question 11 confirms the U.S. Agent must be located in the U.S. with a physical address (no P.O. boxes). Other FAQ entries clarify annual renewal and other obligations.
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Frequently asked questions

Who is required to appoint a U.S. Agent? Any foreign manufacturer or other foreign establishment that manufactures, processes, or imports medical devices into the U.S. must designate a U.S. Agent as part of FDA registration. This includes foreign device manufacturers, contract manufacturers, foreign sterilization or processing facilities, and foreign exporters. If your company is based outside the U.S. and your devices will enter U.S. commerce, you are required to have a U.S. Agent.
Can a foreign company have more than one U.S. Agent? No. FDA regulations allow only one U.S. Agent per foreign establishment. You may change your agent if needed (by updating your registration), but you cannot designate two simultaneously for the same establishment. All communications funnel through the single official U.S. Agent.
Does the U.S. Agent need to reside in the United States? Yes. The U.S. Agent must be located in the U.S. and have a physical U.S. address. A post office box or overseas address does not qualify. The agent can be an individual or a company, but in all cases they must maintain a place of business on U.S. soil where FDA can reach them.
Can our U.S. distributor or an employee of our company serve as the U.S. Agent? Yes. FDA does not restrict who can be the U.S. Agent, as long as they meet the basic criteria (U.S. resident/business and available during business hours). Many foreign firms use their U.S. distributor, subsidiary, or a regulatory consulting firm as the agent. Choose someone trustworthy and ensure they understand the responsibilities. The person or entity must explicitly consent to serve in this role.
Can the U.S. Agent also be the official correspondent for FDA registration? Yes. A foreign establishment may designate the same person as both the U.S. Agent and the official correspondent who manages registration/listing matters. This is optional. If, for example, you hire a regulatory firm, they can act as both your U.S. Agent and handle your registration filings. Just be sure to assign the roles in FDA’s system accordingly.
What are the U.S. Agent’s responsibilities – do they handle FDA submissions or quality issues? The U.S. Agent’s official responsibilities are limited to facilitating communication with FDA: answering FDA’s questions about your imported devices, helping schedule inspections, and receiving FDA documents on your behalf. The agent is not required to prepare submissions (like 510(k) applications) or handle quality compliance tasks – those remain the manufacturer’s responsibility. The agent also is not responsible for reporting adverse events to FDA. Think of the agent as your FDA liaison, not a full regulatory representative.
How do we change our U.S. Agent or update their information? You must update the information in FDA’s FURLS registration system within 10 days of any change. To change the agent, you will enter the new agent’s details and remove the old agent. The new agent will need to confirm via the FDA email verification process. Once confirmed, FDA’s records will reflect the new assignment. Always ensure there is no gap between agents – have the new agent ready to take over immediately when the old one is removed.
What happens if FDA cannot reach my U.S. Agent? FDA will treat an inability to contact your agent the same as an inability to contact you. By regulation, sending information to the U.S. Agent is considered equivalent to sending it to the foreign establishment. So if your agent misses a call or fails to respond to FDA, it’s as if you failed to respond. This could lead to warnings, import delays, or other compliance issues. It’s critical to choose an agent who will be consistently reachable and to keep their contact details up to date.

These resources and Q&As provide a solid grounding in U.S. Agent requirements. If you need more detailed guidance, refer to the FDA links above or consult a regulatory expert. By staying informed, foreign manufacturers can avoid common pitfalls and ensure their U.S. Agent acts as an effective partner in navigating U.S. FDA regulations. 

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