Already submitted the data on the clinical trial and the purpose of the meeting is to review the results and move forward with the clearance steps. Knowing the circumstances it should be a supplement to the last clearance and BAM
the meeting is to discuss how they apply for clearance I don't think it is to discuss the study data but that could come up if it is lacking in anyway
Piggy back as you put it isn't probably possible in the FDA's procedures.
A fresh 501K is or a PMA. how they represent the existing clearance and the new data which they submitted earlier is what they will discuss. They have the Real World Data study as well which is now admissible and wasn't last year.
At the end of the meeting I hope we hear who was in attendance from FDA (Positions at least) and the next actions and anticipated timescale as discussed.
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