US FDA agent representation for Medical Devices and IVD Companies
The United States Food and Drug Administration (FDA) requires all medical device and IVD companies without a presence in the United States to appoint a registered US FDA Agent. The US FDA Agent must be a resident of the United States or maintain a physical place in the US. Your US Agent serves as a liaison between your company and the FDA.
The responsibilities of a US FDA agent:
assisting the FDA in communications with your company
responding to questions concerning your imported products sold in the US
assisting the FDA in scheduling inspections of your facilities.
Assist FDA in communication with the foreign manufacturer
Assist FDA in scheduling inspections of the foreign manufacturer
Initial registration of the new Establishment
Initial listing of medical devices that will be imported
Annual update of registration and listing records
Importation letter template to facilitate importation