US Agent FDA requirements:
- Assisting FDA in communications with the foreign establishment.
- Responding to questions concerning the foreign establishments devices that are imported or offered for import into the United States.
- Assisting FDA in scheduling inspections of the foreign establishment.
- If the FDA is unable to contact the foreign establishment directly or expeditiously, FDA may provide information or documents to the U.S. agent, and such an action shall be considered to be equivalent to providing the same information or documents to the foreign establishment.
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).