Life Science Compliance Update



The FDA Shield – The Medtronic Infuse Case and the Latest Tango of Preemption Versus Liability

Written by , Posted in Enforcement

Robert N. Wilkey, Esq., Staff Writer for Life Science Compliance Update

The U.S. Supreme Court will shortly decide whether it will hear a case that will have a significant impact on the life sciences and medical device industry, specifically on the issue of whether approval by the Food and Drug Administration (FDA) of medical devices for “single limited use” shields and otherwise immunizes manufacturers from product liability suits results from non-FDA approved uses.


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