---
kind: "unit"
title: "21"
title_heading: "Food and Drugs"
key: "chI/subchH/part809"
level: "part"
label: "Part 809"
heading: "In Vitro Diagnostic Products for Human Use"
release: "ecfr-current"
date: "2026-08-27"
url: "https://uscodex.org/cfr/21/chI-subchH-part809"
sections_count: 7
---

# Part 809 — In Vitro Diagnostic Products for Human Use

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-part809-subpartA.md)
- [Subpart B — Labeling](/cfr/21/chI-subchH-part809-subpartB.md)
- [Subpart C — Requirements for Manufacturers and Producers](/cfr/21/chI-subchH-part809-subpartC.md)