---
kind: "unit"
title: "21"
title_heading: "Food and Drugs"
key: "chI/subchH/part861"
level: "part"
label: "Part 861"
heading: "Procedures for Performance Standards Development"
release: "ecfr-current"
date: "2026-08-27"
url: "https://uscodex.org/cfr/21/chI-subchH-part861"
sections_count: 9
---

# Part 861 — Procedures for Performance Standards Development

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-part861-subpartA.md)
- [Subpart B — Procedures for Performance Standards Development and Publication](/cfr/21/chI-subchH-part861-subpartB.md)