Grapefruit USA Inc (GPFT)

[Cowboy200009]

Just a question! Of the existing 510k Approvals how many of these type of devices were reviewed much less Approved ? Just a guess on my part but None due to the fact that this is a new device and technology! The average time for approvals really does not matter, each device may require different amounts of review and I would guess DD on the part of the FDA due to the potential impact in terms of safety, I would guess the uniqueness of device and the technology and I would imagine a whole group of other factors including the obvious ones of structural design, etc.

In a quick review the current approvals from Nov and Dec many if not most were from existing companies with existing products in that market space and many others just new technological add-ons or design changes from those companies and of similar products which are renamed to reflect the some sort of technology or material design change.

I would agree they ( The FDA )appear to be giving Dean a very hard time but would put forth it looks like to me that he is doing everything he can and taking appropriate measures in responding to the requests as he and the company are required to do for any chance of success and obviously we all want to move forward. I personally have never gotten one of these types of devices approved although I imagine its pretty hard and its a pretty complicated procedure. That's just a guess on my part. I personally don't have a lot of friends who have gotten FDA approvals for medical imaging devices lately.

I do not think it will be easy but I do think he and the company have done everything possible and are doing everything possible now to make this happen and I think they will be successful one way or another and I think it will be sooner rather than later based on the product, technology and the amount of work done to date as well as straight perseverance but that is just my guess and of course IMO.

Good Luck to All!