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Title 21

Displaying title 21, up to date as of 9/10/2026. Title 21 was last amended 9/10/2026.
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Title 21Food and DrugsPart / Section
Chapter IFood and Drug Administration, Department of Health and Human Services1 – 1299
Subchapter HMedical Devices800 – 898
Part 812Investigational Device Exemptions812.1 – 812.150
Subpart AGeneral Provisions812.1 – 812.19
Subpart BApplication and Administrative Action812.20 – 812.38
Subpart CResponsibilities of Sponsors812.40 – 812.47
§ 812.40General responsibilities of sponsors.
§ 812.42FDA and IRB approval.
§ 812.43Selecting investigators and monitors.
§ 812.45Informing investigators.
§ 812.46Monitoring investigations.
§ 812.47Emergency research under § 50.24 of this chapter.
Subpart DIRB Review and Approval812.60 – 812.66
§ 812.60IRB composition, duties, and functions.
§ 812.62IRB approval.
§ 812.64IRB's continuing review.
§ 812.65 [Reserved]
§ 812.66Significant risk device determinations.
Subpart EResponsibilities of Investigators812.100 – 812.119
§ 812.100General responsibilities of investigators.
§ 812.110Specific responsibilities of investigators.
§ 812.119Disqualification of a clinical investigator.
Subpart F [Reserved]
Subpart GRecords and Reports812.140 – 812.150
§ 812.140Records.
§ 812.145Inspections.
§ 812.150Reports.