21 CFR Subpart B
Labeling Requirements for Unique Device Identification
June 25, 2020
§
801.20
Label to bear a unique device identifier
§
801.30
General exceptions from the requirement for the label of a device to bear a unique device identifier
§
801.35
Voluntary labeling of a device with a unique device identifier
§
801.40
Form of a unique device identifier
§
801.45
Devices that must be directly marked with a unique device identifier
§
801.50
Labeling requirements for stand-alone software
§
801.55
Request for an exception from or alternative to a unique device identifier requirement
§
801.57
Discontinuation of legacy FDA identification numbers assigned to devices
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