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  1. LII
  2. Electronic Code of Federal Regulations (e-CFR)
  3. Title 21—Food and Drugs
  4. CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES
  5. SUBCHAPTER H—MEDICAL DEVICES
  6. PART 801—LABELING
  7. Subpart B—Labeling Requirements for Unique Device Identification

21 CFR Part 801 - Subpart B - Labeling Requirements for Unique Device Identification

  • CFR
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  1. § 801.20 Label to bear a unique device identifier.
  2. § 801.30 General exceptions from the requirement for the label of a device to bear a unique device identifier.
  3. § 801.35 Voluntary labeling of a device with a unique device identifier.
  4. § 801.40 Form of a unique device identifier.
  5. § 801.45 Devices that must be directly marked with a unique device identifier.
  6. § 801.50 Labeling requirements for stand-alone software.
  7. § 801.55 Request for an exception from or alternative to a unique device identifier requirement.
  8. § 801.57 Discontinuation of legacy FDA identification numbers assigned to devices.

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