Replies to post #24129 on Grapefruit USA Inc (GPFT)

[ltt05]

It comes from the FDAs website and guidelines for decisions on devices.

They aim to reach a decision--be it the need for more information, SE, NSE, or any formal request--on all products submitted with 150 days of submission. In the past two quarters, they have reached a decision on 100% of products within 150 days.

Now, the DViS submission will have been in the FDA's hands for 150 days on/around September 8th without any formal requests or decisions.

[marysawa92]

<<Assyria_Will_Rise - No this is not correct. Nothing is 100% especially not with the FDA. They aren't held accountable to any deadlines on a 510K submission. They have guidelines, but not deadlines. 150 days comes into play and statistically 98% of the submissions receive an answer.

90% of 510(k)s in 90 days
98% of 510(k)s in 150 days

http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Overview/MedicalDeviceUserFeeandModernizationActMDUFMA/ucm109319.htm