The US Food and Drug Administration has set new review timeframes and performance goals for 510(k) 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 510(k) decisions to 124 days from 150 days for fiscal year 2012.
The agency has published guidance explaining regulatory performance goals and 510(k) review process improvements planned for fiscal years 2013 through 2017. These goals are intended to allay industry concerns that the FDA’s 510(k) review process has become too lengthy and complicated.
Through fiscal year 2012, performance goals in terms of FDA 510(k) review timeframes included the following: clearance decisions within 90 days for 90% of submissions received in 2012, and 150 days for 98% of submissions. Starting in 2013, the FDA intends to lower those review times—but those improved review times depend on new obligations on both the regulator and 510(k) applicants under MDUFA III.
The agency seeks to reduce total decision timeframes for 510(k) submissions to 135 days in 2013 and 2014, 130 days in 2015 and 2016, and 124 days in 2017.
