eCFR Reference Browser

§812.1 - Scope.

Title 21, Part 812

§812.10 - Waivers.

Title 21, Part 812

§812.100 - General responsibilities of investigators.

Title 21, Part 812

§812.110 - Specific responsibilities of investigators.

Title 21, Part 812

§812.119 - Disqualification of a clinical investigator.

Title 21, Part 812

§812.140 - Records.

Title 21, Part 812

§812.145 - Inspections.

Title 21, Part 812

§812.150 - Reports.

Title 21, Part 812

§812.18 - Import and export requirements.

Title 21, Part 812

§812.19 - Address for IDE correspondence.

Title 21, Part 812

§812.2 - Applicability.

Title 21, Part 812

§812.20 - Application.

Title 21, Part 812

§812.25 - Investigational plan.

Title 21, Part 812

§812.27 - Report of prior investigations.

Title 21, Part 812

§812.28 - Acceptance of data from clinical investigations conducted outside the United States.

Title 21, Part 812

§812.3 - Definitions.

Title 21, Part 812

§812.30 - FDA action on applications.

Title 21, Part 812

§812.35 - Supplemental applications.

Title 21, Part 812

§812.36 - Treatment use of an investigational device.

Title 21, Part 812

§812.38 - Confidentiality of data and information.

Title 21, Part 812

§812.40 - General responsibilities of sponsors.

Title 21, Part 812

§812.42 - FDA and IRB approval.

Title 21, Part 812

§812.43 - Selecting investigators and monitors.

Title 21, Part 812

§812.45 - Informing investigators.

Title 21, Part 812

§812.46 - Monitoring investigations.

Title 21, Part 812

§812.47 - Emergency research under § 50.24 of this chapter.

Title 21, Part 812

§812.5 - Labeling of investigational devices.

Title 21, Part 812

§812.60 - IRB composition, duties, and functions.

Title 21, Part 812

§812.62 - IRB approval.

Title 21, Part 812

§812.64 - IRB's continuing review.

Title 21, Part 812

§812.65 - Unknown

Title 21, Part 812

§812.66 - Significant risk device determinations.

Title 21, Part 812

§812.7 - Prohibition of promotion and other practices.

Title 21, Part 812

Part 812 - INVESTIGATIONAL DEVICE EXEMPTIONS

Description

Official eCFR Link

§812.1 - Scope.

§812.10 - Waivers.

§812.100 - General responsibilities of investigators.

§812.110 - Specific responsibilities of investigators.

§812.119 - Disqualification of a clinical investigator.

§812.140 - Records.

§812.145 - Inspections.

§812.150 - Reports.

§812.18 - Import and export requirements.

§812.19 - Address for IDE correspondence.

§812.2 - Applicability.

§812.20 - Application.

§812.25 - Investigational plan.

§812.27 - Report of prior investigations.

§812.28 - Acceptance of data from clinical investigations conducted outside the United States.

§812.3 - Definitions.

§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.

§812.5 - Labeling of investigational devices.

§812.60 - IRB composition, duties, and functions.

§812.62 - IRB approval.

§812.64 - IRB's continuing review.

§812.65 - Unknown

§812.66 - Significant risk device determinations.

§812.7 - Prohibition of promotion and other practices.