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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 action items, such as new guidance documents, standard operating procedures,...

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