What is a U.S. Agent for FDA registrations?

A U.S. Agent is a U.S.-based representative designated by certain foreign facilities or firms to serve as the FDA communication point. The U.S. Agent helps facilitate communications between FDA and the foreign company.

Who needs a U.S. Agent?

Foreign facilities that register with FDA for certain product categories commonly must designate a U.S. Agent. Requirements depend on the product category and the company’s role. FDA Registration Assistance can help confirm your requirements.

Can FDA Registration Assistance act as my U.S. Agent?

Yes. FDA Registration Assistance provides professional U.S. Agent services for foreign companies exporting FDA-regulated products to the United States.

What does a U.S. Agent do?

A U.S. Agent serves as a communication link for FDA inquiries, assists with coordination during regulatory communications, and supports updates related to FDA registration records as needed.

Do you provide U.S. Agent services for food, cosmetics, drugs, and medical devices?

Yes. We provide U.S. Agent services across multiple FDA-regulated categories including food, dietary supplements, cosmetics (MoCRA), drugs, and medical devices.

How do I get started with U.S. Agent services?

Contact FDA Registration Assistance and share your company name, product category, country, facility details, and your FDA compliance needs. We will confirm requirements and guide you through the next steps.

Food Facility U.S Agent l FDA Experts

Fee: $429 USD / Per Year

U.S. FDA Agent Services for Foreign Food Facilities

A U.S. FDA Agent is required for all foreign food facilities that manufacture, process, pack, or label food products and import those products into the United States.

As part of FDA Food Facility Registration requirements, foreign establishments must designate a United States Agent (U.S. FDA Agent) to act as the primary liaison between the facility and the U.S. Food and Drug Administration.

Failure to appoint or maintain an active U.S. FDA Agent may result in:

Registration delays or rejection
Inability to import food into the United States
Increased regulatory risk during FDA inquiries or inspections

Responsibilities of a U.S. FDA Agent

The role of a U.S. FDA Agent is defined by FDA regulations and includes four primary responsibilities:

Assisting the FDA with communications involving the foreign food establishment.
Responding to FDA questions or requests related to the foreign facility and its imported products.
Assisting the FDA in scheduling inspections of the foreign establishment when required.
Receiving FDA communications or documents on behalf of the foreign facility if the FDA is unable to contact the establishment directly or promptly.
- Any information or documents provided to the U.S. FDA Agent are considered legally equivalent to being provided directly to the foreign establishment.

Why a Reliable U.S. FDA Agent Matters

Your U.S. FDA Agent plays a critical role in protecting your facility’s FDA registration status and ensuring smooth regulatory communication.

An experienced and responsive U.S. FDA Agent helps:

Prevent missed FDA communications
Reduce regulatory delays
Ensure timely responses to FDA inquiries
Support inspection coordination and compliance

U.S. FDA Agent Services

FDA Registration Assistance is committed to providing reliable, professional, and responsive U.S. FDA Agent servicesfor foreign food facilities worldwide.

Our services include:

Acting as your designated U.S. FDA Agent
Managing FDA communications on your behalf
Supporting FDA inspection coordination
Maintaining ongoing compliance support

To appoint FDA Registration Assistance as your U.S. FDA Agent, please contact us today.

Frequently Asked Questions (FAQ)

What is a U.S. FDA Agent?

A U.S. FDA Agent is a U.S.-based representative designated by a foreign food facility to communicate with the FDA on its behalf.

Who is required to have a U.S. FDA Agent?

All foreign food facilities that manufacture, process, pack, or label food for the U.S. market must appoint a U.S. FDA Agent.

Does the U.S. FDA Agent replace the importer?

No. The U.S. FDA Agent is not the importer of record and does not replace importers or customs brokers. The role is limited to FDA communications and regulatory coordination.