21 U.S.C. § 360k : US Code - Section 360K: State and local requirements respecting devices

Search 21 U.S.C. § 360k : US Code - Section 360K: State and local requirements respecting devices

(a) General rule
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.
(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) 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.