The Supremacy Clause of the U.S. Constitution provides that the 'Laws of the United States … shall be the supreme Law of the Land.' U.S. Const. Art. VI, cl. 2.
Drugs and Devices
The Medical Device Amendments (MDA) to the Food Drug and Cosmetics Act contain an express preemption provision, namely 21 U.S.C. ' 360k(a), which prohibits states from imposing requirements different from, or in addition to, the specific federal requirements imposed on medical devices by FDA regulations. However, the U.S. Supreme Court has held, in a case involving ' 360k(a), that traditional state law claims are permissible and are not preempted if the common law duties involved parallel the duties statutorily imposed in the federal law and do not impose higher standards.
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Janice G. InmanThis premium content is locked for LawJournalNewsletters subscribers only
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