We use cookies on this site to enable your digital experience. By continuing to use this site, you are agreeing to our cookie policy. close

4 Views On Medical Device Preemption

Law360 (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,...
To view the full article, register now.
Law360 Pro Say Podcast
Check out Law360's new podcast, Pro Say, which offers a weekly recap of both the biggest stories and hidden gems from the world of law.