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U.S. Code of Federal Regulations
Regulations most recently checked for updates: Aug 28, 2025
All Titles
Title 21
Chapter I
Part 801
Subpart B - 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.
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