Title 21, Food and DrugsRelease 119-110

§360k State and Local Requirements Respecting Devices

Title 21 › CHAPTER 9 — FEDERAL FOOD, DRUG, AND COSMETIC ACT › SUBCHAPTER V — DRUGS AND DEVICES › Part A — Drugs and Devices › § 360k

Last updated Sep 22, 2026|Official source

Summary

States and local governments cannot make or keep rules about medical devices that are different from or add to federal rules when those rules cover device safety, how well the device works, or any other topic already covered by federal law. A state can ask the federal Secretary for an exception. The Secretary may allow one after notice and an oral hearing if the state rule is stricter than the federal rule, or if it is needed because of compelling local conditions and would not make the device break any federal requirement.

Full Legal Text

Title 21, §360k

Food and Drugs, Source: USLM XML via OLRC

(a)General rule

Except as provided in subsection (b), no State or political subdivision of a State may establish or continue in effect with respect to a device intended for human use any requirement—

(1)which is different from, or in addition to, any requirement applicable under this chapter to the device, and

(2)which relates to the safety or effectiveness of the device or to any other matter included in a requirement applicable to the device under this chapter.

(b)Exempt requirements

Upon application of a State or a political subdivision thereof, the Secretary may, by regulation promulgated after notice and opportunity for an oral hearing, exempt from subsection (a), under such conditions as may be prescribed in such regulation, a requirement of such State or political subdivision applicable to a device intended for human use if—

(1)the requirement is more stringent than a requirement under this chapter which would be applicable to the device 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 to be in violation of any applicable requirement under this chapter.

Reference

Citations & Metadata

Citation

21 U.S.C. § 360k

Title 21, Food and Drugs

Last Updated

Sep 22, 2026

Release point: 119-110