FDA US Agent services
for Medical Devices and more

What a US Agent is?

An US Agent serves as the designated representative for foreign manufacturers exporting food, drugs, medical devices, or other regulated products to the United States. This appointed individual or entity acts as a liaison between the Food and Drug Administration (FDA) and the foreign manufacturer, facilitating communication and ensuring compliance with US regulations. The US Agent assists in matters such as product registration, responding to FDA inquiries, and serving as a point of contact for regulatory issues, playing a crucial role in enabling foreign manufacturers to navigate the complexities of the US market.

 

Any foreign establishment engaged in the manufacture, preparation, propagation, compounding, or processing of a medical device imported into the United States must identify a United States agent (U.S. agent) for that establishment.

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Responsibilities of a US agent

The medical device U.S. agent must either reside in the U.S. or maintain a place of business in the U.S. The U.S. agent cannot use a post office box as an address. The U.S. agent cannot use just an answering service. They must be available to answer the phone or have an employee available to answer the phone during normal business hours.

The responsibilities of the U.S. agent are limited and include:

• assisting FDA in communications with the foreign establishment (medical device manufacturers).

• responding to questions concerning the foreign establishment's medical devices that are imported or offered for import into the United States.

• assisting FDA in scheduling inspections of the foreign medical devices establishment.

• if FDA is unable to contact the foreign medical devices establishment directly or expeditiously. FDA may provide information or documents to the U.S. agent, and such an action shall be considered to be equivalent to providing the same information or documents to the foreign medical devices establishment.