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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
Federal (United States) · Regulations
Part 812 — INVESTIGATIONAL DEVICE EXEMPTIONS
32 sections
6 groups
Subpart A — General Provisions
8 sections
Subpart B — Application and Administrative Action
8 sections
Subpart C — Responsibilities of Sponsors
6 sections
Subpart D — IRB Review and Approval
4 sections
Subpart E — Responsibilities of Investigators
3 sections
Subpart G — Records and Reports
3 sections
Part 812 — INVESTIGATIONAL DEVICE EXEMPTIONS | Federal (United States) Regulations | Justis AI