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FDA U.S. Agent Services for Foreign Manufacturers

FDA U.S. Agent Overview

 

 

Foreign medical device manufacturers without a physical presence in the United States must appoint a U.S. Agent as defined under 21 CFR 807.3(s).

Your FDA U.S. Agent acts as the official point of contact between your company and the U.S. Food & Drug Administration (FDA).

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As your FDA U.S. Agent, we:

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  • Receive FDA communications, notices, and regulatory requests on your behalf

  • Respond to FDA inquiries concerning your devices

  • Forward inspection notices, regulatory correspondence, and enforcement communications

  • Assist in timely communication to ensure you never miss an FDA deadline

  • Acknowledge and coordinate FDA requests during U.S. business hours

 

 

We provide reliable, secure FDA U.S. Agent services—without offering legal advice, regulatory consulting, or product testing.

FDA U.S. Agent Requirements
 

Foreign establishments must designate a U.S. Agent as part of FDA registration and device listing requirements under 21 CFR 807.40.

 

Your FDA U.S. Agent must:

 

  • Be physically located in the United States

  • Be available during normal U.S. business hours

  • Receive and respond to FDA communications related to your device establishment

  • Forward FDA inspection notices and compliance correspondence

  • Assist FDA in communications with the foreign establishment

  • Acknowledge receipt of FDA inquiries, but the U.S. Agent is not responsible for ensuring FDA compliance—that remains with the manufacturer

 

 

Failure to designate an FDA U.S. Agent may delay establishment registration, device listings, and regulatory notifications.

Your Responsibilities

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  • Maintain accurate establishment registration

  • Submit annual FDA registration renewal

  • Maintain complete and accurate device listings

  • Ensure compliance with all FDA regulatory requirements

  • Respond directly to FDA when contacted

  • Provide accurate technical, regulatory, and product information

  • Maintain your own regulatory records and submissions

Our Responsibilities as Your U.S. Agent

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  • Serve as the official FDA point of contact for your establishment

  • Receive all FDA communications (notices, inquiries, inspection announcements, enforcement letters)

  • Forward all FDA requests immediately to your designated contact

  • Acknowledge FDA inquiries as required under 21 CFR 807.3(s)

  • Maintain continuous availability during U.S. business hours

  • Support efficient, reliable communication between your company and FDA

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