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Section 814.1
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Purpose |
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Section 814.2
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Definitions |
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Section 814.3
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Confidentiality of data and information in a premarket approval application (PMA) file |
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Section 814.9
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Research conducted outside the United States |
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Section 814.15
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Service of orders |
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Section 814.17
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Product development protocol (PDP) |
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Section 814.19
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Application |
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Section 814.20
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PMA amendments and resubmitted PMAs |
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Section 814.37
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PMA supplements |
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Section 814.39
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Time frames for reviewing a PMA |
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Section 814.40
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Filing a PMA |
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Section 814.42
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Procedures for review of a PMA |
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Section 814.44
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Denial of approval of a PMA |
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Section 814.45
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Withdrawal of approval of a PMA |
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Section 814.46
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Temporary suspension of approval of a PMA |
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Section 814.47
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General |
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Section 814.80
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Postapproval requirements |
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Section 814.82
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Reports |
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Section 814.84
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Purpose and scope |
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Section 814.100
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Designation of HUD status |
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Section 814.102
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Original applications |
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Section 814.104
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HDE amendments and resubmitted HDE's |
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Section 814.106
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Supplemental applications |
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Section 814.108
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New indications for use |
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Section 814.110
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Filing an HDE |
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Section 814.112
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Timeframes for reviewing an HDE |
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Section 814.114
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Procedures for review of an HDE |
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Section 814.116
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Denial of approval or withdrawal of approval of an HDE |
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Section 814.118
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Temporary suspension of approval of an HDE |
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Section 814.120
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Confidentiality of data and information |
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Section 814.122
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Institutional Review Board requirements |
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Section 814.124
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Postapproval requirements and reports |
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Section 814.126
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Scope |