Monday, August 23, 2010 10:07:18 AM
http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/Overview/MedicalDeviceUserFeeandModernizationActMDUFMA/UCM212876.pdf
You can see that they are actually exceeding their 98% goal within 150 days by getting them all (100%) done within 150 days.
With respect to those that appear to have gone longer, NEPH for example, remember that every applicant who submitted a 510(k) application to the FDA under the prior administration was in the same boat as Imaging3... victims of the total turnover at the FDA. The NEPH application was handed over to a brand new team at the FDA mid-stream just like the DViS application. Accordingly, NEPH's new FDA team, which took over the same time as the DViS review team (late fall 2009) did complete its review of the NEPH application in much less time than 150 days. They already have their answer.
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