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Thursday, October 06, 2011 6:50:25 PM
http://www.nytimes.com/2011/01/20/business/20device.html
............. The F.D.A. said it would impose 25 changes to the device-approval process, including streamlining the reviews for some lower-risk devices. The agency also will also create an internal council to “assure timely and consistent science-based decision making.”
The steps will lead to “a smarter medical device program that supports innovation, keeps jobs here at home, and brings important, safe and effective technologies to patients quickly,” said Dr. Jeffrey Shuren, head of the F.D.A. device unit.
Keeping it real.
Homer
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