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Section 812.1
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Applicability |
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Section 812.2
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Definitions |
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Section 812.3
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Labeling of investigational devices |
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Section 812.5
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Prohibition of promotion and other practices |
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Section 812.7
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Waivers |
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Section 812.10
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Import and export requirements |
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Section 812.18
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Address for IDE correspondence |
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Section 812.19
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Application |
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Section 812.20
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Investigational plan |
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Section 812.25
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Report of prior investigations |
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Section 812.27
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FDA action on applications |
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Section 812.30
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Supplemental applications |
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Section 812.35
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Treatment use of an investigational device |
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Section 812.36
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Confidentiality of data and information |
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Section 812.38
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General responsibilities of sponsors |
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Section 812.40
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FDA and IRB approval |
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Section 812.42
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Selecting investigators and monitors |
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Section 812.43
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Informing investigators |
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Section 812.45
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Monitoring investigations |
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Section 812.46
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Emergency research under Sec |
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Section 812.47
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IRB composition, duties, and functions |
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Section 812.60
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IRB approval |
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Section 812.62
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IRB's continuing review |
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Section 812.64
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Significant risk device determinations |
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Section 812.66
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General responsibilities of investigators |
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Section 812.100
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Specific responsibilities of investigators |
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Section 812.110
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Disqualification of a clinical investigator |
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Section 812.119
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Records |
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Section 812.140
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Inspections |
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Section 812.145
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Reports |
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Section 812.150
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Scope |