Subpart B. Labeling Requirements for Unique Device Identification

• § 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.