---
kind: "section"
citation: "21 U.S.C. § 360k"
title: "21"
title_heading: "Food and Drugs"
number: "360k"
heading: "State and local requirements respecting devices"
release: "119-102"
date: "2026-07-12"
url: "https://uscodex.org/usc/21/360k"
units:
  - "Chapter 9 — Federal Food, Drug, and Cosmetic Act"
  - "Subchapter V — Drugs and Devices"
  - "Part A — Drugs and Devices"
---

# §360k. State and local requirements respecting devices

- (a) **General rule—** Except as provided in [subsection (b)](#b), no [State](/usc/21/321.md?p=a-1) or political subdivision of a [State](/usc/21/321.md?p=a-1) may establish or continue in effect with respect to a [device](/usc/21/321.md?p=h-1) intended for human use any requirement—
  - (1) which is different from, or in addition to, any requirement applicable under this chapter to the [device](/usc/21/321.md?p=h-1), and
  - (2) which relates to the safety or effectiveness of the [device](/usc/21/321.md?p=h-1) or to any other matter included in a requirement applicable to the [device](/usc/21/321.md?p=h-1) under this chapter.
- (b) **Exempt requirements—** Upon application of a [State](/usc/21/321.md?p=a-1) or a political subdivision thereof, the [Secretary](/usc/21/321.md?p=d) may, by regulation promulgated after notice and opportunity for an oral hearing, exempt from [subsection (a)](#a), under such conditions as may be prescribed in such regulation, a requirement of such [State](/usc/21/321.md?p=a-1) or political subdivision applicable to a [device](/usc/21/321.md?p=h-1) intended for human use if—
  - (1) the requirement is more stringent than a requirement under this chapter which would be applicable to the [device](/usc/21/321.md?p=h-1) if an exemption were not in effect under this subsection; or
  - (2) the requirement—
    - (A) is required by compelling local conditions, and
    - (B) compliance with the requirement would not cause the [device](/usc/21/321.md?p=h-1) to be in violation of any applicable requirement under this chapter.

## Source credit

(June 25, 1938, ch. 675, § 521, as added Pub. L. 94–295, § 2, May 28, 1976, 90 Stat. 574.)