FDA Claims Short-Term Success For Pre-Market Device Reforms

With many of its 510(k) and science reforms at least partially implemented, CDRH says it is seeing tangible, positive results. The device center cites a turnaround on multiple measures of review performance following the lows of 2010.

FDA is touting at least short-term success for a series of coordinated reforms it initiated in early 2011 to improve its pre-market review processes for medical devices.

CDRH announced its “plan of action” for the 510(k) program and its approach to science in January 2011, including 36...

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