Justia :: 21 C.F.R. PART 812--INVESTIGATIONAL DEVICE EXEMPTIONS

Justia> Law> United States> Code of Federal Regulations> Title 21 - Food and Drugs> CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES> PART 812--INVESTIGATIONAL DEVICE EXEMPTIONS

21 C.F.R. PART 812--INVESTIGATIONAL DEVICE EXEMPTIONS

TITLE 21--Food and Drugs

CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES

SUBCHAPTER H--MEDICAL DEVICES

PART 812--INVESTIGATIONAL DEVICE EXEMPTIONS

Subpart A--GENERAL PROVISIONS

Scope.

Applicability.

Definitions.

Labeling of investigational devices.

Prohibition of promotion and other practices.

Waivers.

Import and export requirements.

Address for IDE correspondence.

Subpart B--APPLICATION AND ADMINISTRATIVE ACTION

Application.

Investigational plan.

Report of prior investigations.

FDA action on applications.

Supplemental applications.

Treatment use of an investigational device.

Confidentiality of data and information.

Subpart C--RESPONSIBILITIES OF SPONSORS

General responsibilities of sponsors.

FDA and IRB approval.

Selecting investigators and monitors.

Informing investigators.

Monitoring investigations.

Emergency research under 50.24 of this chapter.

Subpart D--IRB REVIEW AND APPROVAL

IRB composition, duties, and functions.

IRB approval.

IRB's continuing review.

§812.65

[Reserved]

Significant risk device determinations.

Subpart E--RESPONSIBILITIES OF INVESTIGATORS

General responsibilities of investigators.

Specific responsibilities of investigators.

Disqualification of a clinical investigator.

Subpart F--[RESERVED]

Subpart G--RECORDS AND REPORTS

Records.

Inspections.

Reports.