Replies to post #24133 on Grapefruit USA Inc (GPFT)

[DAK424]

Please refer to post #23387 by BennyJ. Apparently, the FDA has hit 150 days on ALL of their 510K applications for the past two quarters. It seems reasonable that they will continue this trend in light of the pressure they are receiving from the public as well as Congress.

[IMGGorBust]

It goes a little bit deeper than just the "goals" reported at that link, marysawa. At the end of every quarter, the FDA holds a meeting to report their Quarterly statistics against their Performance Goals. Here is a link to the last quarter's performance against the goals by the CDRH, the division of the FDA managing the DViS application:
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.