Labeling Requirements for Unique Device Identification

  1. Law
  2. CFR 21
  3. Food and Drugs
  4. Food and Drug Administration, Department of Health and Human Services
  5. Medical Devices
  6. Labeling
  7. Labeling Requirements for Unique Device Identification

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Section
801.20

Label to bear a unique device identifier.

Section
801.30

General exceptions from the requirement for the label of a device to bear a unique device identifier.

Section
801.35

Voluntary labeling of a device with a unique device identifier.

Section
801.40

Form of a unique device identifier.

Section
801.45

Devices that must be directly marked with a unique device identifier.

Section
801.50

Labeling requirements for stand-alone software.

Section
801.55

Request for an exception from or alternative to a unique device identifier requirement.

Section
801.57

Discontinuation of legacy FDA identification numbers assigned to devices.