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Definition of Us Agent

A U.S. agent is a registered agent appointed by a foreign facility in the United States or with a business presence in the United States for the purpose of FDA registration. According to FDA regulations, foreign medical device manufacturers must register before entering the United States and appoint a U.S. representative who is responsible for emergency and routine communications.

Us agent duties

U.S. agents serve as a communication link between FDA and foreign plants, responsible for emergency and routine communications. In the event of an emergency, FDA will contact a U.S. agent unless another person is designated as an emergency contact at the time of registration. The U.S. agent represents the foreign facility, and FDA will treat the U.S. agent's representation as that of the foreign facility, and will consider information or documentation provided to the U.S. agent to be equivalent to information or documentation provided to the foreign facility.

Notes for US agents

U.S. agents can't just be mail boxes, voice calls, or places where the personal address of a foreign factory agent doesn't exist. The U.S. agent is responsible for receiving information and documents from the FDA. FDA will contact U.S. agents at random from time to time, and for agents with false information, FDA will require the factory to provide true information, failing which, FDA may impose penalties or even cancel the factory's registration number.

Definition of Us Agent

Notes for US agents

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400-0569-812