Home/U.S. Code/Title 21/Ch. 9/§ 360k
FEDERAL · 21 U.S.C. · Chapter 9

State and local requirements respecting devices

Current through Pub. L. 119-102
Title 21 — Food and Drugs·Ch. 9 — FEDERAL FOOD, DRUG, AND COSMETIC ACT·Subch. V·Pt. A
(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.)