Grapefruit USA Inc (GPFT)

[IMGGorBust]

It is very rare for the FDA to request comparison data like this. No applicant is going to do it without being asked for it. No FDA consultant is going to recommend an applicant do it without the FDA asking for it. The company in this SE letter was surely asked by the FDA for it or they would not have provided it. Our review was done in exactly the same way as this one, and this summary, by the FDA, comes straight from one of the applications that the FDA APPROVED, so there's no can of worms here.

This letter is actually proof that we are in the final stage of the review process, well beyond any possibility of PMA or NSE. Remember all the times that people have pointed to the FDA's 510(k) Process Flow Chart, and noted that at the very bottom, as the last step before SE is found by the FDA, the FDA may require Performance Data? And remember how all of those posters most familiar with the FDA process, myself included, have said: "hey, the radiologist review is the Performance Data that this flow chart is talking about." Well this SE summary from the FDA proves that. It proves that the exact same type of radiologist review done by this other Company and by Imaging3 is what the FDA means when it refers to "Performance Data" in its process flow chart. You don't get to that point on the flow chart until the very end of the process, and we're there. The NSE ship has sailed. The PMA ship has sailed. There are no other boxes between the Performance Data box and SE. The FDA didn't ask for it until the last round because we must not have been at the very end of the process until that request. We're there now. We're finally there.

Lest you ask for a "link" to the oft-posted review flow chart, it's in the iBox, but here it is again for your convenience:
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/PremarketSubmissions/PremarketNotification510k/ucm134783.htm

The FDA follows an order in its review. If we have gotten to a request for Performance Data, which we know now from the FDA's own mouth means a radiologist review just like the one we submitted, then we are past all of the other questions and concerns. The only remaining question was whether the "Performance Data Demonstrates Equivalency." Well, the Performance Data was the Radiologist Review, and Dean said in the last conference call, that not only did it demonstrate equivalency, it actually found superiority. So we are done. Nothing left after that box.