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Friday, March 20, 2015 6:29:47 PM
To those who might know the mechanics of the FDA process better,
I see that there are 5 other devices on the FDA CDRH 515 Projects status website with D task completed.
(http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDRH/CDRHTransparency/ucm240318.htm)
The finalized 515 project history indicates that the FDA completed 3.5 devices per year over a 4 year period. One device has already been finalized in 2015. What are the chances that we are finalized before the other 5 devices with D task completed? Is there a chance that the FDA finalizes this in 2016?!?
Thanks in advance for your reply and input.
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