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.
Third party reviewers authorized by the FDA can cut times by more than half, with applications undergoing independent review taking an average of 72 days last year, but the services cost a pretty penny and the final ruling still rests with FDA regulators.
The good news is that the majority of 510(k)s are cleared with in 6 months, calculated in calendar days rather than "FDA days," which are defined as calendar days during which the application is considered to be "under review" for agency purposes. Only 25% of applications submitted last year were complete within 3 months, Emergo said.
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