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U.S. Code of Federal Regula...
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Title 21-Food and Drugs
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CHAPTER I—FOOD AND DRUG ADM...
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PART 860—MEDICAL DEVICE CLASSIFICATION PROCEDURES
PART 860—MEDICAL DEVICE CLASSIFICATION PROCEDURES
§ 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.
§ 860.84 - Classification procedures for “preamendments devices.”
§ 860.90 - Consultation with panels.
§ 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 “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.