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Code of Federal Regulations (Last Updated: November 8, 2024) |
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Title 21 - Food and Drugs |
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Chapter I - Food and Drug Administration, Department of Health and Human Services |
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SubChapter H - Medical Devices |
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Part 860 - Medical Device Classification Procedures |
| 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 - xxx |
| § 860.15 - xxx |
| Subpart B - Classification |
| § 860.84 - Classification procedures for “preamendments devices.” |
| § 860.90 - xxx |
| § 860.93 - Classification of implants, life-supporting or life-sustaining devices. |
| § 860.95 - Exemptions from sections 510, 519, and 520(f) of the act. |
| 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 - xxx |
| § 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. |
| Subpart D - De Novo Classification |
| § 860.200 - Purpose and applicability. |
| § 860.210 - De Novo request format. |
| § 860.220 - De Novo request content. |
| § 860.230 - Accepting a De Novo request. |
| § 860.240 - Procedures for review of a De Novo request. |
| § 860.250 - Withdrawal of a De Novo request. |
| § 860.260 - Granting or declining a De Novo request. |