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
This law stops states from adding device safety rules beyond federal rules. The FDA can exempt a state rule after a hearing, if it's stricter than federal law. It can also exempt one required by local conditions that doesn't conflict with federal rules.
(a) General rule
Normally, a state or local government cannot make its own rule for a medical device sold for human use if that rule is different from, or adds to, what federal law already requires for that device. This applies whenever the state rule is about the device's safety or effectiveness, or about anything else that a federal requirement already covers.
(b) Exempt requirements
A state or local government can apply to the Secretary* for permission to keep its own device rule in place anyway. The Secretary can only grant this through a formal regulation, issued after giving notice and offering a chance for an oral hearing. The regulation can set conditions on the exemption. The Secretary may grant it if either of two things is true:
- The state's rule is stricter than the federal rule that would otherwise apply, or
- The state's rule is needed because of "compelling local conditions" — special conditions specific to that state or area — and following the state's rule would not cause the device to violate any federal requirement.
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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