Tuesday, August 16, 2022 10:18:24 PM
If BIEL sticks with the same continuous use format and just ups the wattage from 73 to say 125 or less micro watts I'm guessing presription use Clearance should be pretty easy.
If they take a big jump, say 150 micro watts or more it could involve more clinical trials/safety testing which of course would take time.
My gut tells me BIEL wants a quick turnaround on this and will keep the upgrade easy to understand, as in same proven electronics with just a 50% or so power increase. The Pre-Submission Letter should give BIEL an idea of what the FDA will reqiure.
All speculation on my part. May be KN will give more info on the 25th.
Exciting Times at BIEL !!!
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