Monday, November 29, 2010 3:26:06 PM
I read the PR a few times to make sure I did not miss anything. I still have an issue with the information.
The council only reviewed the paperwork they submitted. Meaning they did not see the machine, did not verify its ability, nor was there any mention to that nature.
All that was said is they "believe" that the 510K route is the best route. I heard that before. That there may be a pre-meeting set up with the FDA prior to re-submission.
My question is, if these Pre-Submission meetings are allowed, why is it that IMGG did not take advantage of such a valuable option prior to the submission?
If the response is that Dean was so confident that it would get approved, then that is a very short sided response as any CEO or Executive of a company presented with such an opportunity THEY TAKE ADVANTAGE OF IT. Even if its just to build rapport with the FDA for future submissions or questions.
Was this PR useful to anyone? maybe the PPS today and tomorrow. Nothing else.
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