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...
Samsung Health deployed less-than-reliable blood pressure features in non-US markets while waiting (and in some cases not gettign) FDA clearance. I wonder if NightWatch and Apple may consider releasing the app in laxer markets. People who really need it will then have a gray market way to get access.
