Regulatory

FDA: IDE review times reduced by nearly a year

By Fink Densford

The FDA released a report detailing improvements in clearing medical devices, stating it reduced investigational device exemption times by roughly a year.

In the report, published as part of the agency’s renewal of the Medical Device User Fee act, the federal watchdog covered the agency’s improvements over the past 5 years at hastening its time-to-decision for IDEs, pre-market approvals and 510(k) clearances.

The improvement in IDE clearances was the most distinct, with the FDA saying it reduced the time-to-decision for investigational devices from an average of 442 days in 2011 to only 30 days in 2015. The agency said the percent of IDEs approved within 2 cycles increased from 15% in 2011 to 72% in 2015.

The agency reported distinct reductions in PMA times, from an average time to decision of 352 days in 2009 to 242 days in 2014, clocking a 31% reduction. The agency added that it projected performance for 2014, once all applications are closed, would be on par with 2014.

The agency said it is closing the gap between the fastest and slowest times to PMA approval, reducing the maximum difference from 633 days in 2008 to 197 days in 2014.

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