New 510k timeframe and performance goals at U.S. FDA | MassDevice – Blog entry

The US Food and Drug Administration has set new review timeframes and performance goals for 510k premarket notification reviews of medical devices following Congressional approval of the Medical Device User Fee Amendments of 2012 MDUFA III earlier this year. By 2017, the agency intends to reduce the average total time for 510k decisions to 124 days from 150 days for fiscal year 2012.

via New 510k timeframe and performance goals at U.S. FDA | MassDevice – Blog entry.

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