FAQs
International & Foreign Manufacturer
Q16: Do foreign medical device manufacturers need a U.S. Agent to sell devices in the United States?
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Yes. U.S. Agent representation is legally required under 21 CFR Part 807.40 for all foreign medical device and IVD manufacturers selling into the United States. The FDA will not accept establishment registration, device listing, or premarket submissions (including 510(k)s) from a foreign manufacturer without a valid U.S. Agent on file.
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The U.S. Agent must be physically located in the United States and available to FDA during normal business hours. A P.O. box is not sufficient. The U.S. Agent designation must be updated annually and any time the U.S. Agent changes. This is a common oversight that can result in FDA correspondence reaching an outdated address while response deadlines continue to run. Failure to maintain a valid U.S. Agent can result in FDA refusing to process submissions, detaining product at U.S. customs, and listing the establishment as non-compliant.
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