21 CFR Part 860 — Medical Device Classification Procedures
Subpart B — Classification
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.
Subpart D — De Novo Classification