I think JAA106 said it all, almost.
But to add my 2 cents, this level of concern is not just some conspiracy theory, it is a sad statement of how far reaching the arms of money and power can reach in America. (and other countries) If you don't believe in the possibility of corruption, or lets say 'the freedom to misinterpret in favor of bias' at this level, I have a bridge in Brooklyn that is for sale.
Of course in some people's world, global warming is a liberal plot, OJ simpson was nowhere near the crime scene, Fox news is fair and balanced, and Kenneth Lay was just an innocent bystander. But in this case, it just might be that the FDA is as neutral as your typical MM playing the pink sheets.
What irks me is that this machine could be saving lives as we speak, not to mention helping revive the American presence on the medical technology stage.
I don't buy the conspiracy theory that Dean would go out and hire an expensive firm and go through all this rigamaroll for a machine that is non-functional. Dean has hired a big gun law firm with top level engineers at their disposal, and a former FDA official on their staff. It better work or he is going to look pretty foolish. As consultants, they are not going to advise taking this an inch further without assurance that they have a machine that will survive FDA scrutiny. The adjustments they will make to the 'package' are most likely going to reflect in certain terms stated more carefully in the lexicon of the FDA screeners, and perhaps curtail a few claims in terms of applied function. (just a guess)
I do not mean to imply that there is an outright conspiracy here. I would be more prone to think that the screeners have been pressured from above to find some reason to reject, on a technicality, and they found one or two, and it was something that could have been easily corrected if there were not some pressure to reject. It took so long because they needed to go through everything with a fine-toothed comb... a kind of "find something!" guilty-until-proven-innocent mentality versus the opposite. It will be interesting to see what surfaces.
You can read accounts of this sort of thing happening at federal agencies in articles refered to previously on this board.
OK, so much for my opinion, have at me!