US FDA Agent

US FDA Agent

When is a US FDA Agent required?

A US Agent is required by the Federal Drug Administration (FDA) when a foreign establishment is involved in the manufacture, preparation, or processing of a device that is imported into the United States. The US Agent must reside in the United States and be available to answer questions from the FDA during business hours. During the registration process, an Official Correspondent must be designated as the individual responsible for maintaining the registration and device listing account. Qserve can act as both the US Agent and the Official Correspondent for establishments registered with FDA.