FAQs
International & Foreign Manufacturer

Q18: Can our U.S. distributor serve as our FDA U.S. Agent?

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Yes, a U.S. distributor can legally serve as your FDA U.S. Agent, provided they are physically located in the United States and available to the FDA during business hours. However, even if a distributor is legally permitted to play this role, they may not be ideally suited if they do not have experience in regulatory affairs.

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FDA correspondence, such as deficiency letters, inspection notices, and pre-approval audit requests, is best managed by a partner who understands the regulatory framework, your specific submission, and how to respond accurately and promptly. 

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A distributor whose primary expertise is commercial logistics rather than FDA regulatory affairs may receive and forward correspondence without fully understanding its significance or urgency. This is particularly relevant since the FDA is rapidly evolving and has recently issued new guidance on key aspects of device regulation related to quality management, AI usage, and companion diagnostics.

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