Home/U.S. Code/Title 21/Ch. SUBCHAPTER V—DRUGS AND DEVICES/§ 360k
FEDERAL · 21 U.S.C. · Chapter SUBCHAPTER V—DRUGS AND DEVICES

State and local requirements respecting devices

21 U.S.C. § 360k
Title21 — Food and Drugs
ChapterSUBCHAPTER V—DRUGS AND DEVICES
PartA

This text of 21 U.S.C. § 360k (State and local requirements respecting devices) is published on Counsel Stack Legal Research, covering United States primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

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21 U.S.C. § 360k.

Text

(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 ap

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History

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

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