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.
§ 860.10 - xxx
§ 860.15 - xxx
Subpart B - Classification
§ 860.84 - Classification procedures for “preamendments devices.”
§ 860.90 - xxx
§ 860.93 - Classification of implants, life-supporting or life-sustaining devices.
§ 860.95 - Exemptions from sections 510, 519, and 520(f) of the act.
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 - xxx
§ 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
§ 860.200 - Purpose and applicability.
§ 860.210 - De Novo request format.
§ 860.220 - De Novo request content.
§ 860.230 - Accepting a De Novo request.
§ 860.240 - Procedures for review of a De Novo request.
§ 860.250 - Withdrawal of a De Novo request.
§ 860.260 - Granting or declining a De Novo request.