Ann: Update on US FDA De Novo Classification Request, page-193

Correct dazatoN excellent summation re FDA and very true. RAP team have told it like it is as they are not PR people...to say the least. FDA if they are not doing a go away and don't come back assessment do amost all the time want further and bettervdetails...to cover their backsides and put to rest any future gripes from others. So yep...further and better details will or should do the trick. But do we want to know? So near and yet so far.