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Title 21 - Title 21

Part 860 - MEDICAL DEVICE CLASSIFICATION PROCEDURES

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Details about Part 860

Description

MEDICAL DEVICES - MEDICAL DEVICE CLASSIFICATION PROCEDURES

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16 sections

§860.1 - Scope.

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§860.10 - Implants and life-supporting or life-sustaining devices.

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§860.120 - General.

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§860.123 - Reclassification petition: Content and form.

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§860.125 - Consultation with panels.

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

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§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.

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§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.

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

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

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

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§860.3 - Definitions.

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

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§860.7 - Determination of safety and effectiveness.

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§860.84 - Classification procedures for “preamendments devices.”

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§860.90 - Consultation with panels.

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