The Class 1 is for OTC clearance which would significantly broaden the commercial market. This is obviously a more difficult Class status to get FDA approval, but will be very significant if it happens. That being said, Class 2 can be approved and marketed while still working on Class 1 as data substantiates it's safety and efficacy from ongoing and incoming data.
" The iTBra has gone through a clinical trial in the U.S. and has FDA Class 2 clearance but Royea says they are working on a Class 1 clearance so it can be sold over-the-counter."
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