
From the U.S. Code Online via GPO Access
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[Laws in effect as of January 2, 2001]
[Document not affected by Public Laws enacted between
  January 2, 2001 and January 28, 2002]
[CITE: 21USC360k]

 
                        TITLE 21--FOOD AND DRUGS
 
             CHAPTER 9--FEDERAL FOOD, DRUG, AND COSMETIC ACT
 
                     SUBCHAPTER V--DRUGS AND DEVICES
 
                        Part A--Drugs and Devices
 
Sec. 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.

(June 25, 1938, ch. 675, Sec. 521, as added Pub. L. 94-295, Sec. 2, May 
28, 1976, 90 Stat. 574.)

                  Section Referred to in Other Sections

    This section is referred to in section 360g of this title.
