Under the provisions of the Medical Device Amendments (MDA) to the Food, Drug, and Cosmetic Act certain medical devices are subject to premarket approval of the Food and Drug Administration (FDA). Section 360k(a) of the MDA provides that states may not establish “any requirement” which relates to safety or effectiveness of a medical device and "which is different from, or in addition to" any requirement imposed by the FDA. Until recently, the FDA maintained that § 360k(a) did not preempt most common law tort claims; however, in recent amici briefs, the FDA has aggressively asserted that most, if not all, common law tort claims should be preempted for medical devices that had received PMA approval. This Article discusses the implications of the FDA's new interpretation, and assesses the wisdom of promulgating such an interpretation in amici briefs, rather than in the formal notice-and-comment procedure.

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Tulane Review, Vol. 80, No. 3 (February 2006), pp. 727-775

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