Agree with that kid. They should have been prepared to argue that their device was non-thermal, but that ship has sailed about a year ago when they began the process of the appeal, getting politicians involved, etc.
It's a mess. They can't very well go back and argue for non-thermal when the stink they are making is for thermal.
The entire company is nothing but missed opportunities.
The 'special controls' are extensive enough to put some of these companies out of business. This is the FDA motto - create so many restrictions and hurdles that companies effectively stop marketing their products, all without the FDA really saying 'no'. But that's the end result.
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