FDA 21 CFR Part 812 Investigational Device Exemptions
Controls investigational device studies, sponsor/investigator duties, monitoring, consent and records.
Sectors
Articles (32)
§ 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.§ 812.66 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.