The US Food and Drug Administration (FDA) has announced the time to obtain and submit a unique facility identifier (UFI), a new datapoint required for registration/biennial registration, has been extended to December 31, 2022. Currently, the only acceptable UFI is a DUNS number assigned by Dun & Bradstreet, and the FDA noted that some companies had difficulties obtaining it. Registration and biennial registration renewal are required for foreign and domestic companies that manufacture, process, pack, or hold food for human or animal consumption in the US. The most recent biennial registration renewal ended on December 31, 2020.
The UFI extension is meant to provide companies with more time to obtain a DUNS number. According to FDA’s guidance document published on March 30, 2021, “This guidance also describes our intent not to enforce the associated verification requirements for the remainder of this 2020 biennial registration renewal cycle.”
For additional information on obtaining a UFI or the registration process, please read Deringer’s December 9th trade alert or consult Deringer’s FDA team.