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FDA U.S. Agent Service for Foreign Facilities (Medical Devices & Food Facilities)

Comply with FDA regulations. Get a verified U.S. Agent for FDA registration, communication, and official notice handling — fast, compliant, and affordable.

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  • Instant digital activation
  • Verified U.S. address & phone
  • FDA compliance notifications handled
  • Fast document forwarding
  • Full 12-month coverage
  • Lowest-cost FDA U.S. Agent service in the U.S.

FDA U.S. Agent Requirements — Who Needs One?

Under 21 CFR Part 1 (Food Facility Registration) and 21 CFR 807 (Medical Device Establishment Registration), all foreign manufacturers selling into the U.S. must designate a U.S. Agent.
 
This applies to:
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  • Food facilities exporting to the United States
  • Medical device manufacturers (Class I, II, III)
  • Foreign OEM/ODM facilities
  • Foreign specification developers
  • Contract manufacturers
  • Repackers / relabelers outside the U.S.
 
 
Your FDA U.S. Agent must:
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  • Maintain a physical U.S. address
  • Receive FDA inspection notices & inquiries
  • Respond to FDA on your behalf
  • Be reachable during U.S. business hours
  • Forward all notices promptly to your facility
 
 
Failure to maintain a U.S. Agent may result in:
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❌ Registration invalidation
❌ FDA refusal of your imports
❌ Application/Listing delays
❌ Compliance enforcement actions
 
We provide all required U.S. Agent services.
Verified U.S. Address
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For FDA facility registration and compliance documentation.

U.S. Phone Number
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We receive compliance calls, FDA verification messages, and inspection notices.

Official Correspondence Handling
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We review and forward all FDA notices, inspection communications, enforcement inquiries, and verification requests.

12-mo coverage
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Full one-year U.S. Agent service with no hidden fees.

What Our FDA U.S. Agent Service Includes

Pricing

$349 / year
 
✔ Instant onboarding
✔ 12-month U.S. contact coverage
✔ Verified U.S. address & phone
✔ Unlimited forwarding of FDA notices
✔ Free replacements if FDA re-verifies you

How it works

Step 1 — Sign Up

Pay securely through Stripe to activate your FDA U.S. Agent service.

 

Step 2 — Receive Your U.S. Contact Details

You receive your U.S. address, phone, and FDA U.S. Agent verification sheet immediately.

 

Step 3 — Update Your FDA Registration

Add the provided information to your FDA FURLS account. Most updates take only a few minutes.

 

Step 4 — We handle all FDA communications

We receive and forward inspection notices, verification messages, and enforcement letters — same day.

 

Step 5 — Full 12-month coverage

Your FDA U.S. Agent remains available at any time throughout the year — no additional fees, no hidden charges.

Why Foreign Manufacturers Choose Us

  • Lowest-cost FDA U.S. Agent provider
  • Fast, simple, automated onboarding
  • No hidden fees — flat annual rate
  • Same-day forwarding of all FDA messages
  • Private & secure data handling
  • Experience with both food and device facilities

Frequently Asked Questions

Q: Is this legal under FDA regulations?
Yes. FDA requires a U.S. Agent for all foreign food facilities and medical device manufacturers. We fulfill all FDA Agent requirements.
 
Q: How fast do I get my U.S. Agent information?
Immediately after payment.
 
Q: Does this include FDA submissions or consulting?
No. This is a compliance-only U.S. Agent service.
We do not provide 510(k), label review, or regulatory consulting.
 
Q: What happens if FDA requests an inspection?
We forward the notice instantly and confirm receipt.
You remain responsible for arranging the inspection.
 
Q: Can I use the same U.S. Agent for both food and device facilities?
Yes — as long as they are covered under your annual plan.

Legal Notice:

US Compliance Agent LLC provides U.S. Agent services for compliance and verification purposes only.

We do not provide FDA consulting, regulatory submissions, auditing, or product testing services.

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