(a) In general. A device that must bear a unique device identifier (UDI) on its label must also bear a permanent marking providing the UDI on the device itself if the device is intended to be used more than once and intended to be reprocessed before eac
CFR 21-801.45-2013 history
2013CFR 21-801.45-2013 Food and Drugs. Part801:Labeling. Section801.45:Devices that must be directly marked with a unique device identifier.