---
kind: "unit"
title: "21"
title_heading: "Food and Drugs"
key: "chI/subchH/part807"
level: "part"
label: "Part 807"
heading: "Establishment Registration and Device Listing for Manufacturers and Initial Importers of Devices"
release: "ecfr-current"
date: "2026-08-27"
url: "https://uscodex.org/cfr/21/chI-subchH-part807"
sections_count: 24
---

# Part 807 — Establishment Registration and Device Listing for Manufacturers and Initial Importers of Devices

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-part807-subpartA.md)
- [Subpart B — Procedures for Device Establishments](/cfr/21/chI-subchH-part807-subpartB.md)
- [Subpart C — Procedures for Foreign Device Establishments](/cfr/21/chI-subchH-part807-subpartC.md)
- [Subpart D — Exemptions](/cfr/21/chI-subchH-part807-subpartD.md)
- [Subpart E — Premarket Notification Procedures](/cfr/21/chI-subchH-part807-subpartE.md)