FDA Device Center Must Take Bigger Risks, Director Says

Law360, New York (October 3, 2012, 9:36 PM EDT) -- The Food and Drug Administration's aversion to risk is hindering medical device innovation and investment, and the agency must get comfortable with allowing devices onto the market even with bigger safety risks, the FDA's head device official said Wednesday.

Jeffrey Shuren, the director of the FDA's Center for Devices and Radiological Health, told an annual medical device industry conference that the state of American innovation is one of a patient on life support — and that much of the blame lies on the agency.

“The state...
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