Ann: Oncosil breakthrough device receives CE Marking approval, page-166

Yes interesting thoughts. I'm less sure. Ultimately these regulatory documents are guidance and can't cover every case and could be interpreted in many ways depending on what you want to see. Seems to me this will come down to company's capabilities- how effectively they understand this guidance, negotiate with FDA but also how FDA views their data to work out what they could get away with shifting to post-market. Have to put ourselves in shoes of regulator. . Personally I doubt they'll get a free pass from FDA to market the device for pancreatic cancer in US with no further clinical data pre-market and push everything into post-market collection. Reality check as others have correctly pointed out is Panco has some major limitations, even its safety has been shown in only a small number and efficacy is uncertain.. Would be worth looking at precedent here, quite a few medical devices for serious conditions have got "breakthrough" classification from FDA, so what sort of things did they have to do to get PMA?