Replies to post #32271 on Grapefruit USA Inc (GPFT)

[chevyman]

Why do you assume nse means it's defective? It could be far more advanced than the predicate, thus making it NSE!

[Denunzio36]

I never indicated that. I think that may be on the list, which is why he may have deferred to saying that, as it was still the truth, but WE DON'T KNOW. Criticizing him going with McDermott vs and engineering firm is a bit preemptive. It's not needed.

[dayneyus]

'mr_sano' Your may have generalized this a little bit: The Label is the crux here not the technology. This is very important because the team raised the safety issue after they ask Dean to clarify the USE if you remember? The INTENDED USE is what LABELING is directed toward, and it is the very-thing that got the teams shorts in a bunch, therefore NSE to put us into CLASS III.
It is Important to investors because it is the easiest for us to overcome with a high powered Law team.

'mr_sano' wrote,
"...If the predicate device is not configured in the same manner with like controls then it has to be NSE...."

Here is FDA Guidance on 510K note this excerpt:

A device is substantially equivalent if, in comparison to a predicate it:

* has the same intended use as the predicate; and
* has the same technological characteristics as the predicate;
or
* has the same intended use as the predicate; and


* has different technological characteristics and the information submitted to FDA;
does not raise new questions of safety and effectiveness; and
demonstrates that the device is at least as safe and effective as the legally marketed device.