From FDA’s perspective, for registration purposes, listing the name and contact information for
the U.S. agent in the registration is sufficient to “authorize” the agent, as long as the U.S. agent
has agreed to serve as the U.S. agent for the foreign facility. For its own business reasons,
however, a facility may want to formalize its relationship with the agent with some sort of written
agreement. Regardless of whether there is a formalized relationship between the facility and its
U.S. agent, FDA will verify that the person identified as the U.S. agent for the foreign facility has
agreed to serve as the U.S. agent (see 21 CFR 1.231). (See also section II.E.6 of this document
for a discussion of the verification procedures for U.S. agents).
