FDA United States Agent for Foreign Establishments

In adverse events under the Medical Device Reporting regulation (21 CFR Part 803) or submitting 510(k) Premarket Notifications (21 CFR Part 807, Subpart E), the United States Food and Drug Administration (FDA) requires all medical devices, IVD, and pharmaceutical companies not located (foreign facility) in the United States to appoint a registered FDA US Agent. An appointed FDA United States Agent must be a resident of the United States OR maintain a place of business in the US. Each foreign establishment may designate only one U.S. agent. The foreign establishment should provide the name, address, telephone and fax numbers, and e-mail address of the U.S. agent.

Information about a foreign establishment’s U.S. Agent is submitted electronically the use of the FDA Unified Registration and Listing System (FURLS machine) and is a part of the status quo registration manner. Each overseas establishment can also designate only one U.S. Agent. The overseas established order might also, but is not required to, designate its U.S. Agent as its legit correspondent. The overseas establishment must provide the call, deal with, telephone and fax numbers, and e mail address of the U.S. Agent.