Replies to post #8093 on Grapefruit USA Inc (GPFT)

[chevyman]

My point is, Dean must prove SE, and from his CC, he seemed to imply that the FDA had finally got a grip on the comparisons, I think the software was the FDA sticking point, and now they have that sorted out.

[IMGGorBust]

There is no "limited use"
I'm so tired of people posting here, unchallenged, that Dean submitted a limited use of the DVIS in response to FDA's label inquiry about intended use. Dean could not have been more clear that the FDA was seeking a "more generic" explanation of intended use; i.e., less specific, less tailored, and less limited. Whereas the original lable identified specific procedures and specific functions within a body of medicine, the FDA asked him to be more generic and just state that the device could be used generally in that body of medicine. He gave specific examples on his call for crying out loud. Rather than saying Pediatric surgery, pediatric examinations, pediatric whatever, just say "pediatrics". Accordingly, the potential use of the device was EXPANDED in the revised filing, not made more narrow. Was the only one actually listening to the call?