Title 21, Part 812 — Investigational Device Exemptions

Scope.

Applicability.

Definitions.

Labeling of investigational devices.

Prohibition of promotion and other practices.

Waivers.

Import and export requirements.

Address for IDE correspondence.

Application.

Investigational plan.

Report of prior investigations.

Acceptance of data from clinical investigations conducted outside the United States.

FDA action on applications.

Supplemental applications.

Treatment use of an investigational device.

Confidentiality of data and information.

General responsibilities of sponsors.

FDA and IRB approval.

Selecting investigators and monitors.

Informing investigators.

Monitoring investigations.

Emergency research under § 50.24 of this chapter.

IRB composition, duties, and functions.

IRB approval.

IRB's continuing review.

[Reserved]

Significant risk device determinations.

General responsibilities of investigators.

Specific responsibilities of investigators.

Disqualification of a clinical investigator.

Records.

Inspections.

Reports.