FDA14 Aug 2020 12:42
the submission is due in the next six weeks. FDA may take only 90 days to respond, but what with the high volume of Covid products coming to them, I can't see this happening, especially for a de Novo submission. I believe AN has stated that late Q1 is the most likely time frame - good question to ask at AGM! The other thing to bear in mind is that questions will certainly develop through the process and need to be addressed rapidly to keep the submission moving - this is common with Q submissions.
Ivy, not sure exactly what your question intends - but remember this application is just for one specific usage, so there will be many more submissions to come - a whole pipeline of them. The labs provide a further income stream.