21 CFR
Part 860 Medical Device Classification Procedures
Subpart A - General
- § 860.1 Scope
- § 860.3 Definitions
- § 860.5 Confidentiality and use of data and information submitted in connection with classification and reclassification
- § 860.7 Determination of safety and effectiveness 3 × 483
- § 860.10 Implants and life-supporting or life-sustaining devices
- § 860.15 Exemptions from sections 510, 519, and 520(f) of the Federal Food, Drug, and Cosmetic Act
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