Title 21, Part 860 — Medical Device Classification Procedures

Scope.

Definitions.

Confidentiality and use of data and information submitted in connection with classification and reclassification.

Determination of safety and effectiveness.

Implants and life-supporting or life-sustaining devices.

Exemptions from sections 510, 519, and 520(f) of the Federal Food, Drug, and Cosmetic Act.

Classification procedures for “preamendments devices.”

Consultation with panels.

General.

Reclassification petition: Content and form.

Consultation with panels.

General procedures under section 513(e) of the Federal Food, Drug, and Cosmetic Act.

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.

Procedures when the Commissioner initiates a proceeding to require premarket approval under section 515(b) of the Federal Food, Drug, and Cosmetic Act.

Procedures for reclassification of “postamendments devices” under section 513(f)(3) of the Federal Food, Drug, and Cosmetic Act.

Procedures for transitional products under section 520(l) of the Federal Food, Drug, and Cosmetic Act.

Purpose and applicability.

De Novo request format.

De Novo request content.

Accepting a De Novo request.

Procedures for review of a De Novo request.

Withdrawal of a De Novo request.

Granting or declining a De Novo request.