[moose_ears]

It is true that prescription (Rx) and over the counter (OTC) devices have different requirements, particularly with respect to the instructions for use, and many companies choose to pursue Rx first before expanding to OTC down the line because of this or for unrelated business and marketing reasons. That a product lands in Rx does not necessarily mean that FDA would not be supportive of OTC. FDA has an FAQ on switching from Rx to OTC here: https://www.fda.gov/medical-devices/products-and-medical-pro...