---
kind: "unit"
title: "21"
title_heading: "Food and Drugs"
key: "chI/subchH/part803"
level: "part"
label: "Part 803"
heading: "Medical Device Reporting"
release: "ecfr-current"
date: "2026-08-27"
url: "https://uscodex.org/cfr/21/chI-subchH-part803"
sections_count: 26
---

# Part 803 — Medical Device Reporting

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-part803-subpartA.md)
- [Subpart B — Generally Applicable Requirements for Individual Adverse Event Reports](/cfr/21/chI-subchH-part803-subpartB.md)
- [Subpart C — User Facility Reporting Requirements](/cfr/21/chI-subchH-part803-subpartC.md)
- [Subpart D — Importer Reporting Requirements](/cfr/21/chI-subchH-part803-subpartD.md)
- [Subpart E — Manufacturer Reporting Requirements](/cfr/21/chI-subchH-part803-subpartE.md)