US Agent Services
With more than 20 years of medical device experience and extensive FDA experience serving as US Agent to foreign establishments Vital Compliance is well positioned to serve our clients in the role of US Agent.
To learn more about how Vital Compliance can serve your US Agent needs please contact us at firstname.lastname@example.org
FDA US Agent Responsibilities
Any foreign establishment engaged in the manufacture, preparation, propagation, compounding, or processing of a medical device imported into the United States must identify a United States agent (U.S. Agent) for that establishment.
The US Agent must reside in the United States or maintain a business in the United States. The responsibilities of the US Agent include:
- Assisting FDA in communications with the foreign establishment
- Responding to questions concerning the foreign establishment’s devices that are imported or offered for import into the United States
- Assisting FDA in scheduling inspections of the foreign establishment and
- If FDA is unable to contact the foreign establishment directly or expeditiously, FDA may provide information or documents to the US Agent, and such an action shall be considered to be equivalent to providing the same information or documents to the foreign establishment.