FDA 21 CFR Part 860 Medical Device Classification Procedures

Sathyanarayana M.Sc.
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FDA 21 CFR Part 860 Medical Device Classification Procedures

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Table of contents

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 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

860.84 Classification procedures for “pre amendments devices.”

860.90 Consultation with panels.

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 “post amendments 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 xxx



FDA 21 CFR Part 860 Medical Device Classification Procedures:

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