Federal (United States) · Regulations
Subpart B — Labeling Requirements for Unique Device Identification
8 sections
8 sections
- 21 C.F.R. § 801.20Label to bear a unique device identifier.
- 21 C.F.R. § 801.30General exceptions from the requirement for the label of a device to bear a unique device identifier.
- 21 C.F.R. § 801.35Voluntary labeling of a device with a unique device identifier.
- 21 C.F.R. § 801.40Form of a unique device identifier.
- 21 C.F.R. § 801.45Devices that must be directly marked with a unique device identifier.
- 21 C.F.R. § 801.50Labeling requirements for stand-alone software.
- 21 C.F.R. § 801.55Request for an exception from or alternative to a unique device identifier requirement.
- 21 C.F.R. § 801.57Discontinuation of legacy FDA identification numbers assigned to devices.