All foreign establishments 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. The 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.
Pursuant to FDA requirements, ComplianceAcuity offers U.S. agent services to address the following responsibilities on behalf of any international client:
- Assist FDA in communications with the foreign client,
- Respond to questions concerning the foreign client’s devices that are imported or offered for import into the United States,
- Assist FDA in scheduling inspections of the foreign establishment and
- Receive information or documents from the FDA in cases where FDA is unable to contact the foreign client directly or expeditiously.