The FDA requires that each Foreign Manufacturer must designate a Untied States Agent (U.S. Agent) for that establishment. The U.S. Agent acts a representative on behalf of the foreign manufacturer. The U.S. Agent must reside in the United States or maintain a place of business in the United States. The U.S. Agent cannot use a Post Office Box as an address. The U.S. Agent must be available to answer the phone during normal business hours.
The U.S. Agent has the following responsibilities:
- Assists the FDA in communications with the foreign establishment,
- responds to questions concerning the foreign establishments devices that are imported or offered for import into the United States
- Assists the FDA in scheduling inspections of the foreign establishment and
- If FDA is unable to access the foreign establishment directly , FDA may provide documents to the U.S. agent and such action shall be considered equivalent to providing the same information or documents to the foreign establishment.
NOTE: The US Agent as no responsibility to report adverse events under the Medical Device Reporting regulation or for submitting 510(k) Premarket Notifications.