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Electronic Code of Federal Regulations

e-CFR data is current as of December 5, 2019

Title 21Chapter ISubchapter HPart 812


TITLE 21—Food and Drugs

CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED)

SUBCHAPTER H—MEDICAL DEVICES

PART 812—INVESTIGATIONAL DEVICE EXEMPTIONS

rule

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.
rule

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.
rule

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.
rule

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.
rule

Subpart E—RESPONSIBILITIES OF INVESTIGATORS

§812.100
General responsibilities of investigators.
§812.110
Specific responsibilities of investigators.
§812.119
Disqualification of a clinical investigator.
rule

Subpart F—[RESERVED]

rule

Subpart G—RECORDS AND REPORTS

§812.140
Records.
§812.145
Inspections.
§812.150
Reports.

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