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).
As your FDA U.S. Agent, we:
-
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
-
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
-
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
Scope of Service
Our FDA U.S. Agent service covers FDA regulatory correspondence only. Our address is registered with the FDA under 21 CFR 807.40 (medical devices) or 21 CFR 1.227 (food facilities) as your U.S. Agent and cannot be used for any other purpose.
Our address may not be used as:
-
The manufacturer, distributor, or "Distributed by" address on device labels, food packaging, or product literature (21 CFR 801, 21 CFR 101)
-
The Initial Importer address under 21 CFR 807.3(g) for medical devices
-
A U.S. Distributor, Importer of Record, or shipping address for CBP entries
-
A FSVP Importer address under 21 CFR Part 1 Subpart L for imported food
-
A business mailing address for purposes unrelated to FDA regulatory correspondence