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FDA U.S. Agent for Foreign Food Facilities and Medical Device Establishments

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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We’re your official U.S. point of contact with FDA. We receive FDA communications and forward them to you the same business day. You stay in control of every response.”
 
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We provide reliable, secure FDA U.S. Agent services—without offering legal advice, regulatory consulting, or product testing.
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Before you renew, confirm that your FDA U.S. Agent service is still active, because FDA checks the agent as part of the renewal.

Who needs an FDA U.S. Agent?

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Foreign food facilities. Facilities outside the U.S. that manufacture, process, pack or hold food for U.S. consumption must register with FDA and name a U.S. Agent (21 CFR 1.227). FDA contacts the agent to confirm before it confirms the registration (21 CFR 1.231(a)(5)).
 
Registrations must be renewed between October 1 and December 31 of every even-numbered year, including 2026.
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Foreign medical device establishments. Any foreign establishment that makes or processes a device imported into the U.S. must register, list its devices and designate one U.S. agent (21 CFR 807.40). Changes to the agent’s details must be reported within 10 business days.
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Under both rules, the agent must live in the U.S. or have a place of business there. A mailbox or answering service doesn’t qualify (21 CFR 807.3(s); 21 CFR 1.227).
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If you don’t have one yet, you can appoint an FDA U.S. Agent before starting your registration in FURLS.
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What’s included

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  • U.S. Agent designation for your food facility or device establishment registration
  • Verified U.S. address and phone number for your registration
  • Confirmation of FDA’s U.S. Agent verification request
  • Same-business-day forwarding of FDA correspondence by email
  • 12 months of coverage

Pricing

  • $349 per year, per registration. No setup fee.
  • Coverage renews yearly and stays active through your FDA registration renewals.
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How it works

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  1. Check out. Pay $349 online.
  2. Send your facility details. Company name, facility address and contact person.
  3. Get your U.S. Agent details. Right after checkout, you’ll automatically receive an email with the U.S. Agent name, address, phone and email to enter in your registration.
  4. Register, renew or update with FDA. Food facilities use FURLS (FDA Unified Registration and Listing System); device establishments use FURLS/DRLM (Device Registration and Listing Module).
  5. Confirm and forward. We confirm FDA’s verification request and forward FDA correspondence the same business day.

What we do and don’t do

 

As your U.S. Agent, we:

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  • Receive FDA communications and forward them to you the same business day
  • Help FDA reach your establishment when it asks, including for inspection scheduling (21 CFR 807.40(b)(2))
  • Confirm our role when FDA verifies the designation

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We don’t:

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  • File your registration or renewal
  • Act as your FSVP (Foreign Supplier Verification Program) importer
  • Review labels or give regulatory advice
  • Make decisions or respond to FDA for you. Your team does that.
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Our address may not be used on product labels, as an importer or distributor address, or for shipping.

Frequently asked questions

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Can the same agent serve my food facility and my device establishment?


Yes. Each registration names its own U.S. Agent, and we can serve as both. Each designation is priced separately. Covering both a food facility and a device establishment is $698/year.

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What happens if I don’t renew my food facility registration by December 31, 2026?

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FDA considers it expired and treats the facility as unregistered (21 CFR 1.241(b)). Food from an unregistered foreign facility can be held at the port.

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Is the U.S. Agent the same as the FSVP importer?


No. The FSVP importer is usually your U.S. buyer or consignee (21 CFR 1.500). We act as U.S. Agent only.

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What if FDA calls about an inspection?

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If FDA contacts us about an inspection, we forward it to you the same business day, marked urgent.

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Do you charge to register with FDA?


FDA charges no fee for food facility registration. Device establishments pay FDA’s annual establishment registration fee directly to FDA. Our $349 covers the U.S. Agent service only.

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Business hours


Monday to Friday, 9:00 AM to 5:00 PM ET. FDA correspondence received on a business day is forwarded the same day.
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US Compliance Agent LLC is a private company, not affiliated with FDA or any U.S. government agency. We don’t provide legal advice, regulatory consulting, testing or certification.

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