Founded in 2002, USDeviceAgent.com provides comprehensive U.S. Agent services in accordance with FDA requirements under 21 CFR Part 807, implementing Section 417 of the Food and Drug Administration Modernization Act of 1997.

​

As your designated U.S. Agent, our responsibilities include:

​

• Assisting the FDA in communications with your foreign establishment

• Responding to FDA questions regarding your medical devices imported or offered for import into the United States

• Assisting the FDA in scheduling inspections of your foreign establishment

• Receiving FDA information or documents on your behalf when the FDA is unable to contact your establishment directly or expeditiously