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FEDERAL · 21 CFR

Part 860 — Medical Device Classification Procedures

23 sections · Title 21: Food and Drugs

§ 860.1Scope.
§ 860.3Definitions.
§ 860.5Confidentiality and use of data and information submitted in connection with classification and reclassification.
§ 860.7Determination of safety and effectiveness.
§ 860.10Implants and life-supporting or life-sustaining devices.
§ 860.15Exemptions from sections 510, 519, and 520(f) of the Federal Food, Drug, and Cosmetic Act.
§ 860.84Classification procedures for “preamendments devices.”
§ 860.90Consultation with panels.
§ 860.120General.
§ 860.123Reclassification petition: Content and form.
§ 860.125Consultation with panels.
§ 860.130General procedures under section 513(e) of the Federal Food, Drug, and Cosmetic Act.
§ 860.132Procedures 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.
§ 860.133Procedures when the Commissioner initiates a proceeding to require premarket approval under section 515(b) of the Federal Food, Drug, and Cosmetic Act.
§ 860.134Procedures for reclassification of “postamendments devices” under section 513(f)(3) of the Federal Food, Drug, and Cosmetic Act.
§ 860.136Procedures for transitional products under section 520(l) of the Federal Food, Drug, and Cosmetic Act.
§ 860.200Purpose and applicability.
§ 860.210De Novo request format.
§ 860.220De Novo request content.
§ 860.230Accepting a De Novo request.
§ 860.240Procedures for review of a De Novo request.
§ 860.250Withdrawal of a De Novo request.
§ 860.260Granting or declining a De Novo request.