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Regulations last checked for updates: May 14, 2025

Title 21 - Food and Drugs last revised: May 12, 2025
All TitlesTitle 21Chapter IPart 801Subpart A - Subpart A—General Labeling Provisions
  • § 801.1 - Medical devices; name and place of business of manufacturer, packer or distributor.
  • § 801.3 - Definitions.
  • § 801.4 - Meaning of intended uses.
  • § 801.5 - Medical devices; adequate directions for use.
  • § 801.6 - Medical devices; misleading statements.
  • § 801.15 - Medical devices; prominence of required label statements; use of symbols in labeling.
  • § 801.16 - Medical devices; Spanish-language version of certain required statements.
  • § 801.18 - Format of dates provided on a medical device label.
authority: 21 U.S.C. 321,331,351,352,360d,360i,360j,371,374
source: 41 FR 6896, Feb. 13, 1976, unless otherwise noted.
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