Individuals & Families
Small Businesses
Nonprofits
Employers
Employee Benefits Brokers
PEOs
Credit Unions
Membership Groups
Legal Information
Sign In
/
U.S. Code of Federal Regula...
/
Title 21-Food and Drugs
/
CHAPTER I—FOOD AND DRUG ADM...
/
PART 812—INVESTIGATIONAL DEVICE EXEMPTIONS
PART 812—INVESTIGATIONAL DEVICE EXEMPTIONS
§ 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 - Significant risk device determinations.
§ 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.