(a) Each labeler shall retain, and submit to FDA upon specific request, records showing all unique device identifiers (UDIs) used to identify devices that must bear a UDI on their label, and the particular version or model associated with each device iden
CFR 21-830.360-2013 history
2013CFR 21-830.360-2013 Food and Drugs. Part830:Unique device identification. Section830.360:Records to be maintained by the labeler.