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[A2]
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Electronic Code of Federal Regulations
| e-CFR data is current as of January 16, 2020
TITLE 21—Food and Drugs
CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) SUBCHAPTER H—MEDICAL DEVICES PART 860—MEDICAL DEVICE CLASSIFICATION PROCEDURES
Subpart A—GENERAL
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| Confidentiality and use of data and information submitted in connection with classification and reclassification. |
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| Determination of safety and effectiveness. |
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| Implants and life-supporting or life-sustaining devices. |
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| Exemptions from sections 510, 519, and 520(f) of the Federal Food, Drug, and Cosmetic Act. |
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Subpart B—CLASSIFICATION
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| Classification procedures for “preamendments devices.” |
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| Consultation with panels. |
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Subpart C—RECLASSIFICATION
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| Reclassification petition: Content and form. |
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| Consultation with panels. |
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| General procedures under section 513(e) of the Federal Food, Drug, and Cosmetic Act. |
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| 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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| 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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| Procedures for reclassification of “postamendments devices” under section 513(f)(3) of the Federal Food, Drug, and Cosmetic Act. |
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| Procedures for transitional products under section 520(l) of the Federal Food, Drug, and Cosmetic Act. |
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