Registration & Listing |
U.S. AgentsAny foreign establishment engaged in the manufacture, preparation, propagation, compounding, or processing of a device imported into the United States must identify a United States agent (U.S. agent) for that establishment. Responsibilities of a U.S. AgentThe 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:
Please note that the U.S. agent has no responsibility related to reporting of adverse events under the Medical Device Reporting regulation (21 CFR Part 803), or submitting 510(k) Premarket Notifications (21 CFR Part 807, Subpart E) Updated October 2, 2007 |
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