Federal pre-emption has evolved from the supremacy clause of the U.S. Constitution. When a conflict arises between federal and state law, federal law supersedes state law. There are three forms of pre-emption: express, implied and field pre-emption. Many federal statutes contain express pre-emption provisions that trigger pre-emption.
Section 360(k)(a) is an express pre-emption provision contained in the Medical Device Amendments (MDA) to the federal Food and Drug Act, which pertains to medical devices that are classified by the FDA as Class III medical devices. Class III medical devices include everything from pacemakers to catheters. Section 360(k)(a) of the MDA states that “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.” If a state or political subdivision were to establish such a requirement, then it would be pre-empted by federal law. Such pre-emption does not merely apply to state statutes, but also to state common-law causes of action.
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