FDA’s 21 CFR 807.40(b) states “Each foreign establishment required to register under paragraph (a) of this section shall submit the name, address, and phone number of its United States agent as part of its initial and updated registration information in accordance with subpart B of this part. Each foreign establishment shall designate only one United States agent and may designate the United States agent to act as its official correspondent.” Therefore, if your company is located outside the United States and you wish to have your product imported into the U.S., you must designate someone residing in the United States to act as your company’s U.S. Agent for FDA matters. Regulatory Insight is currently the U.S. Agent for more than 100 companies located outside the United States. We do not charge a recurring annual fee to act as a U.S. Agent, as many consulting companies do; rather we only charge for services rendered as your U.S. Agent. We would be delighted to serve as your company’s U.S. Agent.