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Regulatory Preemption of Medical Devices ( February 2004 )
The FDA has exercised a rigorous pre-market approval process for medical devices since 1976. Yet not all products liability claims involving medical devices are subject to federal regulatory preemption. This article defines the current boundaries between federal and state laws that affect medical devices. -
Proposed FDA Regulation Should Be Opposed ( January 1998 )
This newsletter covers a new rule issued by the Food and Drug Administration regarding the Medical Device Amendments Act of 1976 which would not only expose manufacturers to more lawsuits, it would deny consumers access to some life-saving or life-enhancing products.
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