FAQs
International & Foreign Manufacturer

Q17: How does a U.S. Agent work with the FDA?

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The U.S. Agent is the FDA's designated communication conduit for a foreign manufacturer. Day-to-day responsibilities include receiving and forwarding FDA correspondence, responding to requests for information, helping support inspections, and maintaining current contact details.

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There are limits to the U.S. Agent’s responsibilities. The U.S. Agent is not legally responsible for the device's compliance with FDA requirements. That falls on the foreign manufacturer. It is typically preferable to have a U.S. Agent who understands medical device regulation and has experience with the FDA. A U.S. Agent who doesn't understand your products, your regulatory submissions, or U.S. regulatory processes can introduce significant delays when the FDA asks questions or issues correspondence requiring a substantive response.

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For foreign manufacturers actively navigating FDA submissions, the U.S. Agent relationship is most effective when it's integrated with broader regulatory strategy support. This ensures the person receiving FDA correspondence understands your submission, your quality system, and your regulatory history. Landrich Group has extensive experience advising foreign manufacturers on regulatory submissions and provides U.S. Agent services as part of an integrated regulatory support model.

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