---
kind: "unit"
title: "21"
title_heading: "Food and Drugs"
key: "chI/subchH/part821"
level: "part"
label: "Part 821"
heading: "Medical Device Tracking Requirements"
release: "ecfr-current"
date: "2026-08-27"
url: "https://uscodex.org/cfr/21/chI-subchH-part821"
sections_count: 10
---

# Part 821 — Medical Device Tracking Requirements

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-part821-subpartA.md)
- [Subpart B — Tracking Requirements](/cfr/21/chI-subchH-part821-subpartB.md)
- [Subpart C — Additional Requirements and Responsibilities](/cfr/21/chI-subchH-part821-subpartC.md)
- [Subpart D — Records and Inspections](/cfr/21/chI-subchH-part821-subpartD.md)