Replies to post #40350 on Grapefruit USA Inc (GPFT)

[Boxsterfan]

Wait, they got a 3rd party review and the 3rd party didn't steal their idea? How novel...

[Dr. Mugs]

HH...You are kidding..right??? Did you happened to read the FDA's A.I. letter dated Oct.23, 2009 They told him that his device had a new indication that altered the diagnostic effect, impacting safety and effectiveness, and is therefore a new intended use. The BodyTom got a third party review based on the fact that this device is class 2, The Dvis is now a class 3 device and will need to do a PMA. No doubt about that in my mind! There is no predicate for the Dvis to be compared to... period...amen!!PMA on the way!!!! A class 3 device can not use a class 2 device as a predicate.