21 CFR Part 812
PART 812—INVESTIGATIONAL DEVICE EXEMPTIONS
- PART 812—INVESTIGATIONAL DEVICE EXEMPTIONS
- Chapter I—Food and Drug Administration, Department of Health and Human Services › Subchapter H—Medical Devices
- 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 § 50.24 of this chapter.
- 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.
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