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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 A—General Labeling Provisions

21 CFR Part 801 - Subpart A - General Labeling Provisions

  • CFR
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  1. § 801.1 Medical devices; name and place of business of manufacturer, packer or distributor.
  2. § 801.3 Definitions.
  3. § 801.4 Meaning of intended uses.
  4. § 801.5 Medical devices; adequate directions for use.
  5. § 801.6 Medical devices; misleading statements.
  6. § 801.15 Medical devices; prominence of required label statements; use of symbols in labeling.
  7. § 801.16 Medical devices; Spanish-language version of certain required statements.
  8. § 801.18 Format of dates provided on a medical device label.

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