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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 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.

The following state regulations pages link to this page.



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