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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 860Subpart C - Subpart C—Reclassification
  • § 860.120 - General.
  • § 860.123 - Reclassification petition: Content and form.
  • § 860.125 - Consultation with panels.
  • § 860.130 - General procedures under section 513(e) of the Federal Food, Drug, and Cosmetic Act.
  • § 860.132 - Procedures when the Commissioner initiates a performance standard or premarket approval proceeding under section 514(b) or 515(b) of the Federal Food, Drug, and Cosmetic Act.
  • § 860.133 - Procedures when the Commissioner initiates a proceeding to require premarket approval under section 515(b) of the Federal Food, Drug, and Cosmetic Act.
  • § 860.134 - Procedures for reclassification of “postamendments devices” under section 513(f)(3) of the Federal Food, Drug, and Cosmetic Act.
  • § 860.136 - Procedures for transitional products under section 520(l) of the Federal Food, Drug, and Cosmetic Act.
authority: 21 U.S.C. 321(h), 353(g), 360c, 360d, 360e, 360i, 360j, 371, 374
source: 43 FR 32993, July 28, 1978, unless otherwise noted.
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