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  1. Regulations
    All Titles
  2. title 21
    Food and Drugs
  3. chapter I-i7
    CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED)
  4. part 801
    PART 801—LABELING
  5. subpart B
    Subpart B—Labeling Requirements for Unique Device Identification

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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