Federal report finds time lags in FDA medical device reviews

03/30/2012 | Modern Healthcare (subscription required)

A Government Accountability Office report says that although the FDA has achieved most of its performance objectives for the 510(k) clearance process for medical devices, the agency has not consistently done so for premarket approval applications. The report also notes that the time it took to get final PMA or 510(k) decisions rose between fiscal 2003 and fiscal 2010.

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