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FDA U.S. Agent

U.S. Agent for the Purpose of FDA Registration

After a foreign facility submits a registration, FDA will verify that the person or entity identified as the U.S. Agent has agreed to serve.

The FDA sends a confirmation notification of a foreign facility registration to the U.S. Agent, to ensure that the U.S. Agent is aware of the connection.

The agency will not confirm any registration or provide the foreign facility with a registration number until the U.S. Agent’s confirmation within 30 days.

Because U.S. Agents have direct access to a list of facilities identifying them as U.S. Agents, the system will limit the number of unauthorized and or fraudulent U.S. Agents listings.

U.S. Agents can also electronically notify FDA that they decline to serve as or no longer serve as the U.S. Agent for a foreign facility.

If the U.S. Agent wishes to no longer serve the already registered foreign facility, the foreign facility will have 60 calendar days to update the facility’s registration with a new U.S. Agent.

FDA U.S. Agent

However, in most cases, the registration of the foreign company is simply processed by the U.S. Agent, upon request and payment of a service fee.

Fake U.S. Agent Used for FDA Registration

​More than 1,300 companies used one fictitious address and U.S. Agent information to register with the FDA and exported products that did not meet U.S. requirements, just to avoid paying U.S. Agent Service Fees. And, that may be the tip of an iceberg.

How and When to Hire a U.S. Agent

Foreign establishments or facilities exporting to the United States must identify an FDA U.S. Agent during the registration process. Each foreign establishment may designate only one U.S. Agent.

FDA treats representations by the U.S. Agent as those of the foreign facility, and will consider information or documents provided to the U.S. Agent, the equivalent of providing the information or documents to the foreign facility.

Therefore, most foreign establishments or facilities expect their U.S. Agent to be at least bilingual.

Also, time zones not just in the U.S., but around the world are usually challenging. U.S. Agents working hours can make a difference.

Email exchanges are great when responses are provided the same day. But, additional instant and 24/7 live support chat is much better.

Ready to switch U.S. Agent? October 1 through December 31, each year, is the best time frame.

Get the service your company deserves, at the cost you can afford.


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