US Agent for FDA Registration

Assigning US Agent for FDA Registration is a requirement. foreign food/drug/medical device establishment registering with the FDA for the sale/marketing of their product in the US must designate a US agent. The Us agent information for the establishment is submitted using the FDA Unified Registration and Listing System (FURLS) during the establishment registration process.

 

The US agent must be residing in the US or have a business address in the US and must be available to answer telephonic communications. The US agent is responsible for assisting in communications between FDA and the establishment; assisting FDA with scheduled inspections; FDA may choose to provide information to the US agent if unable to directly contact establishment.