FDA US Agent

What does an FDA US agent do?

Every medical device company 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 assists the FDA in communication with the device company. The most common communications concern questions about devices exported to the US and scheduling FDA inspections.

When is the ideal time to change your FDA US agent?

You can change US agents at any time. In all likelihood, your current agent will not give you a refund of any kind. However, if you wait until October 1, you will not be able to complete the registration renewal process without your current US agent getting involved, because you can’t change the US agent until the annual establishment registration user fee is paid the registration is renewed.

Is there any certification or contract required for a US agent?

FDA US agents have no certification process, but you should have a formal signed agreement or contract with your agent. I have never seen the FDA request a copy of the contract or a letter from a US agent or the company that is registered. However, since the agent has a legal role and responsibility, you should ensure an agreement or contract is in place.

What does the FDA do to qualify an FDA US agent?

The FDA does very little to qualify an FDA US agent. The only thing the FDA “does” is to send an automated email to the FDA US agent when you submit your initial establishment registration or renew your FDA registration. The email subject line is “ACTION REQUIRED: U.S.

What is an “Action Required” email?

Below is an example of the “Action Required” email that the FDA sends to FDA US agents immediately after your registration and listing is completed by a foreign firm. Your FDA US agent will receive an automated email from the FDA seconds after you complete your registration for an initial FDA establishment registration or the renewal of your FDA establishment registration.