It's a firestorm! The FDA announced that makers of certain older and risky medical devices will have to prove that their products are safe and effective according to the New York Times. This is a very hot issue. Related to this, I just read an editorial published by NEJM (the New England Journal of Medicine): The Medical Device Safety Act of 2009. Who's side are you on? The patient? Industry? Litigation attorneys? Others?
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Do we really want the keystone cops at the FDA to have the final word on device safety? (http://tinyurl.com/cjzovr) I think not...
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