Source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?CFRPart=812&amp;showFR=1
Timestamp: 2019-04-20 14:44:24+00:00

Document:
§ 812.5 - Labeling of investigational devices.
§ 812.7 - Prohibition of promotion and other practices.
§ 812.18 - Import and export requirements.
§ 812.19 - Address for IDE correspondence.
§ 812.25 - Investigational plan.
§ 812.27 - Report of prior investigations.
§ 812.28 - Acceptance of data from clinical investigations conducted outside the United States.
§ 812.30 - FDA action on applications.
§ 812.35 - Supplemental applications.
§ 812.36 - Treatment use of an investigational device.
§ 812.38 - Confidentiality of data and information.
§ 812.40 - General responsibilities of sponsors.
§ 812.42 - FDA and IRB approval.
§ 812.43 - Selecting investigators and monitors.
§ 812.45 - Informing investigators.
§ 812.46 - Monitoring investigations.
§ 812.47 - Emergency research under 50.24 of this chapter.
§ 812.60 - IRB composition, duties, and functions.
§ 812.62 - IRB approval.
§ 812.64 - IRB's continuing review.
§ 812.66 - Significant risk device determinations.
§ 812.100 - General responsibilities of investigators.
§ 812.110 - Specific responsibilities of investigators.
§ 812.119 - Disqualification of a clinical investigator.
Source: 45 FR 3751, Jan. 18, 1980, unless otherwise noted.

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