Thanks, I had a look at some announcements and I can see from below that company is in contact with FDA since April 2021 and then FDA responded that 510(k) not available to PIQ so they should apply through "De NOVO" pathway and based on below announcement company supposed to submit for "De Novo" in Q1 2022 so before March 2022 ... but I can't find any announcement which says company has done such submission so what is stopping or stopped company to apply for "De Novo" pathway for last 14 months as below announcement came out on November 2021 (
https://newswire.iguana2.com/af5f4d73c1a54a33/piq.asx/6A1064457/PIQ_FDA_advises_regulatory_pathway_for_PromarkerD_in_US) .. !
does anyone know why such a novel thing wasn't submitted for last 14 month for "De Novo" application ? As company made comment they will do submission so they should have come back to you all with explanation in last 14 month on why or when they doing it ? as it supposed to be by March 2022... !!... let me know if such submission was done and i missed it so i can go back and read more announcements !
This forum is to share opinion and not necessary agree to everything or sing la-la songs ... if you don't know answer then it's fine and if you know then share ... and if you don't want to share what you know then also fine but no need to agitate like kids who normally get agitated when you ask question about maths while they wanted to start eating candy
.... in my opinion.. !
Now it would be good if someone knows what happened to FDA plans ? Also what happened to CLIA ?
(20min delay)