FDA 21 CFR Part 812 Investigational Device Exemptions

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Table of contents

Subpart A - General Provisions

812.1 Scope.

812.2 Applicability.

812.3 Definitions.

812.5 Labeling of investigational devices.

812.7 Prohibition of promotion and other practices.

812.10 Waivers.

812.18 Import and export requirements.

812.19 Address for IDE correspondence.

Subpart B - Application and Administrative Action

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.

812.30 FDA action on applications.

812.35 Supplemental applications.

812.36 Treatment use of an investigational device.

812.38 Confidentiality of data and information.

Subpart C - Responsibilities of Sponsors

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

Subpart D - IRB Review and Approval

812.60 IRB composition, duties, and functions.

812.62 IRB approval.

812.64 IRB's continuing review.

812.65 [Reserved]

812.66 Significant risk device determinations.

Subpart E - Responsibilities of Investigators

812.100 General responsibilities of investigators.

812.110 Specific responsibilities of investigators.

812.119 Disqualification of a clinical investigator.

Subpart F [Reserved]

Subpart G - Records and Reports

812.140 Records.

812.145 Inspections.

812.150 Reports.

FDA 21 CFR Part 812 Investigational Device Exemptions: