---
kind: "unit"
title: "21"
title_heading: "Food and Drugs"
key: "chI/subchH/part814"
level: "part"
label: "Part 814"
heading: "Premarket Approval of Medical Devices"
release: "ecfr-current"
date: "2026-08-27"
url: "https://uscodex.org/cfr/21/chI-subchH-part814"
sections_count: 33
---

# Part 814 — Premarket Approval of Medical 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](/cfr/21/chI-subchH-part814-subpartA.md)
- [Subpart B — Premarket Approval Application (PMA)](/cfr/21/chI-subchH-part814-subpartB.md)
- [Subpart C — FDA Action on a PMA](/cfr/21/chI-subchH-part814-subpartC.md)
- [Subpart D — Administrative Review [Reserved]](/cfr/21/chI-subchH-part814-subpartD.md)
- [Subpart E — Postapproval Requirements](/cfr/21/chI-subchH-part814-subpartE.md)
- [Subpart F-G — Subparts F-G [Reserved]](/cfr/21/chI-subchH-part814-subpartF-G.md)
- [Subpart H — Humanitarian Use Devices](/cfr/21/chI-subchH-part814-subpartH.md)