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US law
Federal (United States)
Regulations
Title 21 CFR — Food and Drugs
Chapter I — FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES
Part 812 — INVESTIGATIONAL DEVICE EXEMPTIONS
Subpart D — IRB Review and Approval
Federal (United States) · Regulations
Subpart D — IRB Review and Approval
4 sections
4 sections
21 C.F.R. § 812.60
IRB composition, duties, and functions.
21 C.F.R. § 812.62
IRB approval.
21 C.F.R. § 812.64
IRB's continuing review.
21 C.F.R. § 812.66
Significant risk device determinations.
Subpart D — IRB Review and Approval | Federal (United States) Regulations | Justis AI