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Hot Topic Does Riegel v. Medtronic, Inc. Affect You? Yes, probably more than you realize. On February 20, 2008, in Riegel v. Medtronic, Inc., the U.S. Supreme Court found that common law tort claims challenging the safety and effectiveness of devices that require premarket approval (PA) under the Medical Device Amendments of 1976 (MDA) are preempted by federal law. This case does not apply to devices that are marked under a premarket notification, also known as a §510(k) devices. Prior results do not guarantee a similar outcome.
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