US FDA Agent

According to the United States Food and Drug Administration (FDA), “Any foreign establishment engaged in the manufacture, preparation, propagation, compounding, or processing of a device imported into the United States must identify a United States agent (US agent) for that establishment.”

“The US agent must either reside in the US or maintain a place of business in the US”

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, and
  • 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 US agent.  This will be considered the equivalent of providing the same information or documents to the foreign establishment.

CENIT Consulting can provide US Agent services through our US Operations, including preparation of documents as requested.

Contact us to find out more about our US Agent Service