The Official Correspondent focuses on communication with the FDA about your establishment registration and your devices listed with the FDA. Also, the OC does not need to be located in the US. However, every foreign company registered with the FDA must appoint a US Agent who has a physical residence or place of business in the US to assist with specific FDA related responsibilities. The US Agent is responsible for FDA questions about imported devices and helps with FDA inspection scheduling, as well as communication related to the inspection.
