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FDA Pre-IDE Average Review Time Swells to 5 Months!
September 3, 2010, Rockville, MD. In the official review of ODE performance which came out yesterday, the average review time for 510(k) submittals remained at the 90 day mark for FY2009. Buried close to the last page was that the average review time for Pre-IDE's had grown from 90 in FY2008 to over 150 in FY2009. According to the report, the main reason for this is the sheer number of Pre-IDE submissions has grown significantly due to the complexity and combinations of products for which a clinical study is planned. Missing from the report is how effective the Pre-IDE process was which admittedly may be difficult for FDA to quantify. CRO Group clients availing themselves of Pre-IDE have found it useful in arriving at basic clinical study critical points to support their approval submissions. The report may be found at http://bit.ly/cqXe3S. For more information on how CRO Group may be of assistance in designing your clinical study with a Pre-IDE, please send an email with "Pre-IDE" in the subject line to info@crogroup.com