What We Do
We act as your designated U.S. Agent for FDA registration and forward regulatory communications by email.
U.S. Agent Representation for FDA Registration
We provide U.S. Agent designation for foreign manufacturers exporting products to the United States.
- Simple onboarding
- Email-based communication
- Fixed annual pricing
U.S. Agent Service
$350 / year
- U.S. Agent designation
- Forwarding of FDA communications
- 12 month service
Independent Compliance Service
US FDA Compliance is a private regulatory support service and is not affiliated with the FDA.
Email-Based Process
All communication is handled through email to ensure clear documentation and simple onboarding.
How the Process Works
Step 1
Email us to request service.
Step 2
We send you an invoice and onboarding guide.
Step 3
After payment, you receive our U.S. Agent information.
Step 4
Enter our details during your FDA facility registration.
Step 5
We confirm the U.S. Agent appointment in the FDA system.
U.S. Agent Representation
$350 per year
This service provides a designated U.S. Agent for your FDA registration and includes forwarding of regulatory communications received from the FDA.
Included Services
- U.S. Agent contact designation
- FDA communication forwarding
- Email support
- 12-month service period
FAQ
What is a U.S. Agent?
A U.S. Agent is a U.S.-based contact designated by certain foreign companies during FDA registration processes.
Who needs a U.S. Agent?
Foreign manufacturers exporting regulated products to the United States may be required to designate a U.S. Agent during FDA registration.
How do I get started?
Email us and we will send an invoice and onboarding instructions.
How long does service last?
The service period is 12 months from the date of designation.
When do I pay?
Payment is required before the U.S. Agent appointment is confirmed.
Ready to appoint a U.S. Agent?
Email us to begin the onboarding process.
Email info@usafdacompliance.com