All medical device and IVD companies that are not based in the US and are required to register with FDA are required by the US Food and Drug Administration (FDA) to designate a registered US FDA Agent. The US FDA Agent must either reside in the US or have a physical office there. The FDA and your business are connected through your US Agent.

What are the responsibilities of U.S. Agents?

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 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 U.S. agent, and such an action shall be considered to be equivalent to providing the same information or documents to the foreign establishment.

Contact Medreg for U.S. Agent services for reliable regulatory representation, professional support, and seamless coordination with the US FDA to help meet your medical device regulatory obligations.