---
kind: "unit"
title: "21"
title_heading: "Food and Drugs"
key: "chI/subchH/part812"
level: "part"
label: "Part 812"
heading: "Investigational Device Exemptions"
release: "ecfr-current"
date: "2026-08-27"
url: "https://uscodex.org/cfr/21/chI-subchH-part812"
sections_count: 33
---

# Part 812 — Investigational Device Exemptions

Title 21 C.F.R. — Food and Drugs › Chapter I — Food and Drug Administration, Department of Health and Human Services › Subchapter H — Medical Devices

## Contents

- [Subpart A — General Provisions](/cfr/21/chI-subchH-part812-subpartA.md)
- [Subpart B — Application and Administrative Action](/cfr/21/chI-subchH-part812-subpartB.md)
- [Subpart C — Responsibilities of Sponsors](/cfr/21/chI-subchH-part812-subpartC.md)
- [Subpart D — IRB Review and Approval](/cfr/21/chI-subchH-part812-subpartD.md)
- [Subpart E — Responsibilities of Investigators](/cfr/21/chI-subchH-part812-subpartE.md)
- [Subpart F — Subpart F [Reserved]](/cfr/21/chI-subchH-part812-subpartF.md)
- [Subpart G — Records and Reports](/cfr/21/chI-subchH-part812-subpartG.md)