Title 21

PART 801 SUBPART B

Subpart B - Labeling Requirements for Unique Device Identification

• 21 U.S.C. 321, 331, 351, 352, 360d, 360i, 360j, 371, 374.
• 41 FR 6896, Feb. 13, 1976, unless otherwise noted.

21:8.0.1.1.2.2.1.1	SECTION 801.20	801.20 Label to bear a unique device identifier.
21:8.0.1.1.2.2.1.2	SECTION 801.30	801.30 General exceptions from the requirement for the label of a device to bear a unique device identifier.
21:8.0.1.1.2.2.1.3	SECTION 801.35	801.35 Voluntary labeling of a device with a unique device identifier.
21:8.0.1.1.2.2.1.4	SECTION 801.40	801.40 Form of a unique device identifier.
21:8.0.1.1.2.2.1.5	SECTION 801.45	801.45 Devices that must be directly marked with a unique device identifier.
21:8.0.1.1.2.2.1.6	SECTION 801.50	801.50 Labeling requirements for stand-alone software.
21:8.0.1.1.2.2.1.7	SECTION 801.55	801.55 Request for an exception from or alternative to a unique device identifier requirement.
21:8.0.1.1.2.2.1.8	SECTION 801.57	801.57 Discontinuation of legacy FDA identification numbers assigned to devices.

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