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U.S. Code of Federal Regulations
Regulations most recently checked for updates: Aug 28, 2025
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Title 21
Chapter I
Part 860
Subpart 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.
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