4 Views On Medical Device Preemption

Law360, New York (March 24, 2011, 12:41 PM EDT) -- In 1976, the Medical Device Amendments (MDA) to the Food, Drug and Cosmetics Act created a comprehensive federal regulatory scheme for medical devices,[1] which included requiring manufacturers of the riskiest medical devices — known as Class III devices — to obtain premarket approval from the U.S. Food and Drug Administration before selling such devices to the public.[2]

In exchange, Congress provided manufacturers with protection from states requiring them to follow more stringent, or even simply different, standards when making or marketing their medical devices. More specifically,...
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