21 CFR Subpart C
Reclassification
June 25, 2020
§
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