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CDRH Touts Progress On Clinical Study Reviews

The device center says that the number of review cycles and the median review time for investigational device exemptions dropped ahead of expectations during the past year. Aggressive goals remain for 2015.

FDA's device center says it is well ahead of the goals it set for itself to improve the investigational device exemption review process, but it still has aggressive improvements planned for the current year.

The number of IDE studies that required more than two cycles of review prior to approval dropped by 34 percent in FY 2014 compared to 2013 as of Oct. 31, CDRH reported Jan. 21. That is ahead of the goal it set in February 2014 to reduce reviews that require more than two go-arounds by 25 percent

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