Code of Federal Regulations Title 21. Food and Drugs § 21.251.11 Official contact and U.S. agent for Foreign Sellers

(1) Ensuring the accuracy of registration information as required by § 251.9;  and

(2) Reviewing, disseminating, routing, and responding to all communications from FDA, including emergency communications.

(1) A Foreign Seller must designate a single U.S. agent. The U.S. agent must reside or maintain a place of business in the United States and may not be a mailbox, answering machine or service, or other place where a person acting as the U.S. agent is not physically present. The U.S. agent is responsible for:

(2) FDA may provide certain information and/or documents to the U.S. agent. The provision of information and/or documents by FDA to the U.S. agent is equivalent to providing the same information and/or documents to the Foreign Seller.