Not trying to chip on you either. Just using your post to vent some measured frustration with both FDA and Dean.
FDA because, let's be honest, their pretty f'ed up. They're a group of paper-pushing functionaries with limited grasp of that which they are entrusted to evaluate...they are no doubt partly aware of their own limitations and so are doubly reluctant to approve that which they don't fully understand for fear of appearing foolish by okaying something that winds up hurting somebody...being govt employees, they've got the brass ring of employment/pension/health insurance for life provided they don't do one thing: hurt somebody. So it's safer to delay, obfuscate, stall, and simulate competence by appearing to be thoughtfully judicious.
Frustrated with Dean because when faced with the bureaucratic disaster that is FDA, he underestimated the threat, acted to raise expectations too high and overestimated his own ability to deal with FDA's capriciousness. I'd very much like to see him do himself and his investors a huge favor and get some outside expertise. There's consultants out there who would laugh at someone having done five 510(k)s, there's guys who've literally done hundreds and could no doubt provide additional perspective, another set of eyes, etc. to the app. I believe in Dean on many levels and am confident in his product; I sometimes wonder whether he is too confident in himself.
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