The contact for device identification designated under § 830.320(a) shall provide FDA with the following information concerning each version or model of a device required to bear a unique device identifier (UDI) on its label:
CFR 21-830.310-2013 history
2013CFR 21-830.310-2013 Food and Drugs. Part830:Unique device identification. Section830.310:Information required for unique device identification.