never said they did, I said if FDA is comparing that machine to DVIS (per applicate equivalence 510k). If they are not and IMGG has used another type of machine to compare it with, then that would explain the need to narrow the intended use and the request for images. Of course this brings is own problems, but that is the nature of the beast and why I think Dean shot for the gold ring on equivalence rather then going the longer route, but its his machine he does what he feels he can do best. The sooner the better is what I want, just hope this is not another delay (and there has been a lot through the years)
I am not saying we are dead, or anything stupid like that. I started this whole post to show, what a lot of people have been telling people(and what dean told us) is not true, or better, not correct.
The notion that intended use is a label is true, but only post 510k approval. People argue about this because they don't understand it. There are stages to the process... application, determination and then post approval. Well the intended use being clarified with the request for more images being closely time related shows that we are clearly not in post approval land, but squarely in determination process.
I could bash and say this could be still in application process, but that isn't what I think at all. It wouldn't make sense unless the FDA uses images as part of the application. If that is true, then that would bring this into a different light, but I have not heard that they need images to apply but that could be my mistake.
But it is clear that intended use clarification is used in determination and application, and not only labeling (all this is show in flow chart from FDA itself) So that is why i corrected it. Now it looks like I am a basher, when all I am is someone who does not want to pump or bash but actually participate in a discussion based on correct information. Then go from there, I focus on the worst case because i have always been taught to hope for the best but plane for the worse
