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The Medical Device Amendments of 1976 (MDA) created a scheme offederal safety oversight for medical devices while sweeping back stateoversight schemes. The statute provides that a State shall not “es-tablish or continue in effect with respect to a device intended for hu-man use any requirement—. . . (1) which is different from, or in addi-tion to, any requirement applicable under [federal law] 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 de-vice under” relevant federal law. 21 U. S. C. §360k(a). The MDA calls for federal oversight of medical devices that varies with the type of device at issue. The most extensive oversight is reserved for Class III devices that undergo the premarket approval process. These de-vices may enter the market only if the FDA reviews their design, la-beling, and manufacturing specifications and determines that thosespecifications provide a reasonable assurance of safety and effective-ness. Manufacturers may not make changes to such devices that would affect safety or effectiveness unless they first seek and obtainpermission from the FDA.Charles Riegel and his wife, petitioner Donna Riegel, brought suit against respondent Medtronic after a Medtronic catheter ruptured in Charles Riegel’s coronary artery during heart surgery. The catheter is a Class III device that received FDA premarket approval. The Riegels alleged that the device was designed, labeled, and manufac-tured in a manner that violated New York common law. The District Court held that the MDA pre-empted the Riegels’ claims of strict li-ability; breach of implied warranty; and negligence in the design,