"Prior to submitting a De Novo request to the FDA, we recommend you consider submitting a pre-submission to obtain feedback from the appropriate premarket review division." thats what the FDA say.
Once we receive feedback then FDA de novo can be prepared and submitted. Should take a further 6 months at least for the approval to go through? I think it will look like early 2021.
Also the Qtrly for March last year came out end of April, so we might be 2 weeks away from that.
PainChek General Discussion, page-13776
-
- There are more pages in this discussion • 6,637 more messages in this thread...
You’re viewing a single post only. To view the entire thread just sign in or Join Now (FREE)
