US Agent and EU Authorized Representative Services
If you operate outside the U.S., but wish to sell or distribute product in the US, you need a US Agent. If you operate in the US, but wish to sell or distribute product in the EU, you need an EU Authorized Representative.
US Agent and EU Representative Service
Assist FDA in communications with the your non-US establishment
Respond to questions concerning the your non-US establishment’s devices that are imported or offered for import into the U.S.
Assist FDA in scheduling inspections of the your non-US establishment
Assist with FDA inspections
Receive information or documents from the FDA on behalf of your non-US
establishment in the absence of effective communication between the two