<<Come on. The notion that FDA is pressured because Europe approved device first is ludicrous. I've seen plenty of examples that something already got approved in Europe actually got rejected by FDA because FDA wanted additional tests... >>
True statement however, with the added pressure from the admission of MELA being wronged at the Congressional Committee and press reviews, what do you think they are going to look like now that MELA has CE Mark approval? Granted, probably doesn't make much difference to them. If the Congressional Committee would truly like to see the FDA revamp, they should have a case study done on how the MELA application has been handled.