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What is MDA Preemption in Medical Device Liability about?

This document summarizes a court case regarding whether federal law preempts state tort law claims against medical device manufacturers. The court held that: 1) Section 360k(a) of the Medical Device Amendments, which provides for federal preemption of state requirements regarding medical devices, applies to state tort law claims. 2) There is no exception to the preemption clause for cases where manufacturers fail to comply with federal requirements, even if they fraudulently obtained federal approval of

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Scribd Government Docs

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EN