https://www.folioconsultinggroup.com/post/you...-what-does
https://www.cc.nih.gov/orcs/ide/fda-responses
Error made but NAMSA can bring the process together.
The PMA reasonable assurance standard under 21 CFR 860.7 is a different and higher bar than IDE approvability, and failing to distinguish between the two is one of the most consequential planning errors we see in early-stage Class III programs. Bet those 30 days may be running! Hmmm!