Ann: ResApp Submits De Novo Application to the FDA, page-39

hi all as per the fda de novo classification, the fda must have a written response to RAP whether it's a de novo device or not within 120 days. if it is then they are allowed to market it immediately. if it's determined not to be de novo it will be classified as a class 2/3 and will undertake a whole other approval process.

I will be surprised if rap and it's consultants have not already made a good case for de novo.

what I'm getting at is FDA de novo classifications (approval) by 13 Aug 19 or end of sep if it's business days.

if rap did a pre-submission to the FDA, which is optional, then they will most likely have a even greater chance of De novo classification.

this announcement is massive!!! hope people realise it