2016 US Code
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
| 21 U.S.C. § 360k (2016) |
| §360k. State and local requirements respecting devices |
|
(a) General rule
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— (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), 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. |
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(June 25, 1938, ch. 675, §521, as added Pub. L. 94–295, §2, May 28, 1976, 90 Stat. 574.) |
| United States Code, 2012 Edition, Supplement 4, Title 21 - FOOD AND DRUGS |
| Bills and Statutes |
| United States Code |
| Y 1.2/5: |
| 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 |
| section 360k |
| 2016 |
| January 6, 2017 |
| No |
| standard |
| 90 Stat. 574 |
| Public Law 94-295 |
