What information must the U.S. agent have on the foreign facility? For example, does the U.S. agent need to know and understand the company and product? Or is it sufficient for the U.S. agent to be able to contact the manufacturer quickly in case of emergency, as well as serve as a conduit for the general information flow to and from FDA?

Under 21 CFR 1.227, there are two qualifications for a U.S. agent. The agent:

1. must reside or maintain a place of business in the United States; and
2. must be physically present in the United States. Although the U.S. agent is not required to know and understand the facility’s company
   and product, the U.S. agent must be able to serve as the communication link between FDA and the foreign facility because FDA will contact the foreign facility’s U.S. agent when an emergency occurs (unless the registration specifies another emergency contact). Thus, at a minimum, the U.S. agent needs to know whom to contact at the facility if any emergency arises.