FDA programs that require a U.S. Agent
Four FDA registration programs require a foreign facility to name a U.S. Agent: food facility registration (21 CFR 1.227), medical device establishment registration (21 CFR 807.40), drug establishment registration (21 CFR 207.69) and cosmetic facility registration under MoCRA (FD&C Act §607). Each has its own renewal cycle.
FDA US Agent for Foreign Food Facilities
21 CFR 1.227, 1.230–1.235Renew every even-numbered year, October 1 to December 31 (21 CFR 1.230(b))
FDA US Agent for Foreign Medical Device Establishments
21 CFR 807.40Renew annually between October 1 and December 31 (21 CFR 807.22)
FDA US Agent for Foreign Drug Establishments
21 CFR 207.69Renew annually between October 1 and December 31 (21 CFR 207.29)
FDA US Agent for Foreign Cosmetic Facilities (MoCRA)
FD&C Act §607 (MoCRA)Renew every 2 years