21 U.S.C. § 360K
Section 360k · State and local requirements respecting devices
This is § 521 of the All Kids Act
Amended 2 times on record
Applied in 721 court decisions — leading case Medtronic, Inc. v. Lohr (1996)
Most recently applied in Monsanto v. Durnell (U.S. 2026, slip opinion) (June 2026)
Applied most in the Ninth Circuit Circuit (40 decisions)
Cases citing this section usually also cite 21 U.S.C. § 360C · 21 U.S.C. § 360E · 21 U.S.C. § 301
How often courts cite this section
Court decisions citing this, by year.Markers show enactment, consequential amendments, and circuit splits over this section — watch for a citation surge after a change or a disagreement. The dip in the last several years is a data-coverage gap, not a real trend — our corpus holds fewer opinions from the most recent years, so recent citations are undercounted.
Except as provided in subsection (b) of this section, 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.
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) of this section, 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.