21 C.F.R. PART 860--MEDICAL DEVICE CLASSIFICATION PROCEDURES
TITLE 21--Food and Drugs
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES
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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Subpart B--CLASSIFICATION
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| Classification procedures for ''old devices.''
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| Classification of implants, life-supporting or life-sustaining devices.
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| Exemptions from sections 510, 519, and 520(f) of the act.
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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 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 act.
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| Procedures for ''new devices'' under section 513(f) of the act and reclassification of certain devices.
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| Procedures for transitional products under section 520(l) of the act.
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