Again, FDA has nothing to consider until RDGL submits an IDE application. I'm not the only one who has called out RDGL for the bogus Twiitter statement.
In pre-submission discussions with FDA, FDA reviews whatever RDGL has asked them to and makes suggestions on what they expect to see in strong IDE application. They aren't reviewing the device for human trials at that point, just coaching RDGL on the application. And most of the FDA review of submissions like a draft IDE happens well before the meeting. Meetings are needed if issues arise that must be talked through.
We'll know we're in end game when FDA cancels a meeting and it stays cancelled. What one want's to hear back from FDA is: Looks great. No meeting needed. Go ahead and submit IDE upon completion of xyz.
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