CDRH Touts Progress On Clinical Study Reviews
This article was originally published in The Gray Sheet
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.
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According to the latest numbers, CDRH says it has reduced median investigational review exemption review times to 30 days, and three out of four IDEs are now fully approved after two review cycles.
In an interview with “The Gray Sheet,” CDRH’s Acting Clinical Trials Director Owen Faris discusses the device center’s new pre-market clinical trials program aimed at speeding up approval times for investigational device exemptions and increasing the number of IDE trials in the U.S.
CDRH Director Jeffrey Shuren discussed the device center’s two-year strategic priorities with “The Gray Sheet.” The center plans to rebalance pre-market and post-market data collection, when appropriate, and improve the processes for starting up clinical trials in the U.S.