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Part 812
FEDERAL · 21 CFR
Part 812 — Investigational Device Exemptions
33 sections · Title 21: Food and Drugs
§ 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
§ 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.