---
kind: "unit"
title: "21"
title_heading: "Food and Drugs"
key: "chI/subchH/part801"
level: "part"
label: "Part 801"
heading: "Labeling"
release: "ecfr-current"
date: "2026-08-27"
url: "https://uscodex.org/cfr/21/chI-subchH-part801"
sections_count: 38
---

# Part 801 — Labeling

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 Labeling Provisions](/cfr/21/chI-subchH-part801-subpartA.md)
- [Subpart B — Labeling Requirements for Unique Device Identification](/cfr/21/chI-subchH-part801-subpartB.md)
- [Subpart C — Labeling Requirements for Over-the-Counter Devices](/cfr/21/chI-subchH-part801-subpartC.md)
- [Subpart D — Exemptions From Adequate Directions for Use](/cfr/21/chI-subchH-part801-subpartD.md)
- [Subpart E — Other Exemptions](/cfr/21/chI-subchH-part801-subpartE.md)
- [Subpart F-G — Subparts F-G [Reserved]](/cfr/21/chI-subchH-part801-subpartF-G.md)
- [Subpart H — Special Requirements for Specific Devices](/cfr/21/chI-subchH-part801-subpartH.md)