What does an FDA US Agent do?

Every medical device company located outside the USA, that distributes devices in the USA, must have an FDA US agent. This includes manufacturers, contract manufacturers, and specifications developers outside the USA. The US agent is responsible for assisting the FDA in communication with the device company. The most common communications concern questions about devices exported to the US, and scheduling FDA inspections.

The role of the US agent is very similar to a European Authorized Representative, a UK Responsible Person, or a Swiss Authorised Representative.

Unlike an EC Representative, you do not include US agents in your device labeling. The US agent's name and contact information only appears on your FDA Establishment Registration record on the FDA website.

If you have additional questions, or your need a US agent, please contact Medical Device Academy:

➤ https://medicaldeviceacademy.com/cont...

You can also find more information in our most recent blog (to be published later today, 5-9-2023):
➤ https://medicaldeviceacademy.com/fda-...