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Section 860.1
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Definitions |
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Section 860.3
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Confidentiality and use of data and information submitted in connection with classification and reclassification |
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Section 860.5
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Determination of safety and effectiveness |
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Section 860.7
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Classification procedures for ``old devices |
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Section 860.84
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Classification of implants, life-supporting or life-sustaining devices |
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Section 860.93
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Exemptions from sections 510, 519, and 520(f) of the act |
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Section 860.95
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General |
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Section 860.120
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Reclassification petition: Content and form |
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Section 860.123
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Consultation with panels |
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Section 860.125
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General procedures under section 513(e) of the act |
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Section 860.130
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Procedures when the Commissioner initiates a performance standard or premarket approval proceeding under section |
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Section 860.132
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Procedures for ``new devices'' under section 513(f) of the act and reclassification of certain devices |
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Section 860.134
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Procedures for transitional products under section 520(l) of the act |
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Section 860.136
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Purpose and scope |