21 U.S.C. § 360k — State and local requirements respecting devices
submitted 88 years ago by Pub. L. 94-295 to r/title-21-FOOD-AND-DRUGS · 200 words · no verdicts yet
A translation hasn’t been published for this section yet. The official text below is complete and authoritative.
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—
which is different from, or in addition to, any requirement applicable under this chapter to the device, and
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), 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—
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
the requirement—
is required by compelling local conditions, and
compliance with the requirement would not cause the device 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.)
- 1938Enacted · Pub. L. 94-295 · 90 Stat. 574
A history note hasn’t been published yet. The record shows enactment by Pub. L. 94-295 on 1938-06-25.
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