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U.S. Department of Health and Human Services

CFR - Code of Federal Regulations Title 21
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The information on this page is current as of Dec 22, 2023.

For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR).

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TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER H - MEDICAL DEVICES
 
PART 812INVESTIGATIONAL DEVICE EXEMPTIONS
 

Subpart A - General Provisions
   § 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.

Subpart B - Application and Administrative Action
   § 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.

Subpart C - Responsibilities of Sponsors
   § 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.

Subpart D - IRB Review and Approval
   § 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.

Subpart E - Responsibilities of Investigators
   § 812.100 - General responsibilities of investigators.
   § 812.110 - Specific responsibilities of investigators.
   § 812.119 - Disqualification of a clinical investigator.

Subpart F [Reserved]

Subpart G - Records and Reports
   § 812.140 - Records.
   § 812.145 - Inspections.
   § 812.150 - Reports.

Authority: 21 U.S.C. 331, 351, 352, 353, 355, 360, 360c-360f, 360h-360j, 360bbb-8b, 371, 372, 374, 379e, 379k-1, 381, 382, 383; 42 U.S.C. 216, 241, 262, 263b-263n.
Source: 45 FR 3751, Jan. 18, 1980, unless otherwise noted.

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