As a registered U.S. Agent, we provide healthcare consulting assistance with U.S. registration and service for your medical device or pharmaceutical product.
Any foreign establishment engaged in the manufacture, preparation, propagation, compounding, or processing of a drug or a device product imported into the United States must identify a U.S. Agent for that establishment.
U.S. Agent Responsibilities
The responsibilities of the U.S. Agent are limited and include:
- Assisting FDA in communications with the foreign establishment
- Responding to questions concerning the foreign establishment’s drug or device products that are imported or offered for import into the United States
- Assisting FDA in scheduling inspections of the foreign establishment
- If 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), or Postmarketing reporting of adverse drugs experiences (21 CFR 314.80).