Grapefruit USA Inc (GPFT)

[BennyJ]

- Do you know how much time it took for the medtronic o-arm imaging system's upgrade. I remind you. it's just an upgrade, that means comparing with their own existing predicate device(existing o-arm imaging system). It took more than 10 months. It was filed last year and was approved in june-july time frame. Normally it didn't take that long for an upgrade. It is because of the last year reviewer team of CDRH head.
- I did a complete research on 08 & 09 radiation emitting devices especially imaging system. Most of them took way more than expected time frame due to the inefficient performance of the last reviewer team. I can tell you what happened. FDA implemented new MDUFMA goals starting from 2007 october. All the cycle goal rules are gone, I mean 60, 75, 90 days cycle goals. They have to follow new goals such as 90% in 90 days and 98% in 150 days. What they did is that they just approved minor complex applications within 90 days time frame and medium complex applications within 150 days range. They didn't even care to look at the complex or new innovative applications at all even though they are substantially equivalent. But they managed to meet their goal for 2008 since they have to report it to congress. They just left less than 2% apps for the whole year, showing some stupid reasons such as (labelling issue, manual changes etc, it happened in IMGG case too)
- other reason is that in 08 & 09, huge media buzz on radiation emitting device. Last reviewer team didn't want to get in further trouble in approving those devices.
- Now the time has changed after new approver's team who came on board this year beginning. They care about the applicants and innvoative devices. That's why they do regular townhall meetings in major cities all over US in regular interval and they revamping and improving processes more effieciently. More to come based on the public comments. I know one software was waiting for more than 22 months. This was reported earlier.

With above said, Now we are golden.
We passed thru everything and performance/radiologist review submitted in april 5th. FDA is interacting. No more questions asked after the last CC. We are on the wait mode. We could be hearing approval news any day soon.