FDA Looks To Streamline Device Approval Process

Law360, New York (August 4, 2010, 12:09 PM EDT) -- The U.S. Food and Drug Administration’s Center for Devices and Radiological Health released on Wednesday two preliminary reports recommending steps the unit could take to improve patient safety, enhance regulatory predictability and foster medical device innovation.

The agency is seeking public comment on its findings, which include proposals to streamline the 510(k) review process for lower-risk novel devices that cannot be cleared under the current guidelines but do not warrant more rigorous premarket approval, and to make better use of scientific experts outside the FDA....
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