Report: FDA 510(k)s times up 50% since 2006 | MassDevice.com On Call

An analysis conducted by Emergo Group finds that FDA 510(k) applications take an average of 166 day to go from initial submission to final decision, 56 days longer than they took in 2006.

MASSDEVICE ON CALL — Review times have increased significantly for the FDA's fast-track 510(k) pathway, taking an average of about 50% longer today than they took in 2006, according to an industry report.

An Emergo Group analysis found that 510(k) applications cleared in 2013 took about 166 days to go from initial submission to final decision, compared with only 110 days in 2006. Still, current review times are down from a peak of 176 days in 2011.

News Well, On Call, Regulatory/Clearance, 510(k), Food & Drug Administration (FDA)

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