Part 812 — Investigational Device Exemptions
Current through Sep 8, 2026
Authority: 21 U.S.C. 331, 351, 352, 353, 355, 360, 360c-360f, 360h-360j, 360hh-360pp, 360rr-360ss, 360bbb-8b, 371, 372, 374, 379e, 381, 382; 42 U.S.C. 216, 241, 262.
Source: 45 FR 3751, Jan. 18, 1980, unless otherwise noted.
Sections
- § 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.
- § 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.
- § 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.
- § 812.65 [Reserved]
- § 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.
- § 812.140 Records.
- § 812.145 Inspections.
- § 812.150 Reports.