Foreign medical device manufacturers exporting products to the United States must appoint a U.S. Agent registered with the FDA. The U.S. Agent serves as the official liaison between the FDA and the foreign establishment.
Key responsibilities include:
- Assisting the FDA with communications involving the foreign manufacturer.
- Responding to FDA questions regarding devices imported into the United States.
- Helping coordinate and schedule FDA inspections of the foreign facility.
- Receiving official FDA communications and documents when the agency cannot contact the foreign establishment directly.
PLEASE NOTE THAT THE U.S. AGENT HAS NO RESPONSIBILITY RELATED TO REPORTING OF ADVERSE EVENTS UNDER THE MEDICAL DEVICE REPORTING REGULATION (21 CFR PART 803) OR SUBMITTING 510(K) PREMARKET NOTIFICATIONS (21 CFR PART 807, SUBPART E).
