FDA US Agent: Complete Guide for Foreign Companies (2026)

By KECC FDA Consulting · Updated April 2026 · 8 min read

If your company is located outside the United States and you export food, drugs, medical devices, or cosmetics to the US market, you are almost certainly required by law to designate an FDA US Agent. This guide explains everything you need to know.

      Key takeaway: An FDA US Agent is not optional. It is a legal requirement under 21 CFR for foreign establishments. Failure to designate one can result in your products being refused entry at US ports of entry.
    

What Is an FDA US Agent?

An FDA US Agent (also called a US Agent for FDA purposes) is a person or company physically located in the United States who serves as the official communication link between a foreign establishment and the US Food and Drug Administration (FDA). The US Agent receives official correspondence from the FDA on behalf of the foreign establishment and must be available during US business hours.

Who Is Required to Have an FDA US Agent?

The FDA US Agent requirement applies to foreign establishments in the following categories:

Food facilities: Foreign facilities that manufacture, process, pack, or hold food for human or animal consumption in the US (required under 21 CFR 1.227)
Drug establishments: Foreign drug manufacturers, repackers, and relabelers (required under 21 CFR 207.69)
Medical device establishments: Foreign device manufacturers, specification developers, and initial importers (required under 21 CFR 807.40)
Cosmetics facilities: Foreign cosmetics facilities subject to MoCRA registration (required since July 2024)

What Does an FDA US Agent Do?

The FDA US Agent serves several critical functions:

Official point of contact: Receives all official FDA communications, including inspection notices, warning letters, and import alerts
Inspection facilitation: Assists with scheduling and facilitating FDA inspections of the foreign establishment
Registration maintenance: Helps maintain accurate FDA registration information
Emergency contact: Available 24/7 for urgent FDA communications

How to Appoint an FDA US Agent

The process for appointing an FDA US Agent varies slightly by product category, but generally involves:

Selecting a qualified US Agent (a person or company physically located in the US)
Registering your establishment with the FDA through the appropriate system (FURLS for food and devices, SPL for drugs)
Providing your US Agent's contact information during registration
Renewing registration annually (for food) or biennially (for devices)

KECC FDA US Agent Service

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We provide FDA US Agent service for food, drug, device, and cosmetics facilities. Upon signing up, we immediately register as your US Agent in the FDA's system. You receive a confirmation letter within 24 hours.

Frequently Asked Questions

Can my US importer serve as my FDA US Agent?

Yes, your US importer can serve as your FDA US Agent, provided they agree to take on this responsibility and meet the requirements. However, many importers prefer not to take on this legal obligation, and using a dedicated FDA US Agent service is often cleaner from a liability perspective.

What happens if I don't have an FDA US Agent?

If your establishment is required to have a US Agent but doesn't have one, the FDA may refuse admission of your products at US ports of entry. Your establishment may also be subject to enforcement action.

Can a foreign company serve as an FDA US Agent?

No. The FDA US Agent must be physically located in the United States. A foreign company or individual cannot serve as an FDA US Agent.

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