This article attempts to reconcile the competing purposes of the MDA, and to offer one alternative to effectuate Congress' purposes without preempting some claims and permitting others. First, this article will describe the arrangement of the MDA, including the classification provisions for medical devices and the preemption provision of the MDA. Next, this article will interpret the caselaw regarding preemption in general, and specifically preemption of state tort claims by the MDA. Finally, this article seeks to reconcile two competing purposes of Congress in enacting the MDA through implied preemption of state tort claims, with exceptions for devices which have never been subjected to the Food and Drug Administration's (FDA) pre-market approval process, or for which such approval was gained fraudulently.
Theresa J. Pulley Radwan, Meeting the Objectives of the MDA: Implied Preemption of State Tort Claims by the Medical Device Amendments, 10 J.L. & Health 343 (1995-1996)