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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 D - Subpart D—Exemptions From Adequate Directions for Use
  • § 801.109 - Prescription devices.
  • § 801.110 - Retail exemption for prescription devices.
  • § 801.116 - Medical devices having commonly known directions.
  • § 801.119 - In vitro diagnostic products.
  • § 801.122 - Medical devices for processing, repacking, or manufacturing.
  • § 801.125 - Medical devices for use in teaching, law enforcement, research, and analysis.
  • § 801.127 - Medical devices; expiration of exemptions.
  • § 801.128 - Exceptions or alternatives to labeling requirements for medical devices held by the Strategic National Stockpile.
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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