2 ms·
Looks like the FDA has some labeling requirements and a requirement to make this app prescription only, which probably pushed the company down this route.
by Closi 4y ago
Looks like the FDA has some labeling requirements and a requirement to make this app prescription only, which probably pushed the company down this route.
- mgarfias 4y agoYep. I don’t blame NightWare here. Stupid fda
- moose_ears 4y agoIt 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-procedures/over-counter-otc-medical-devices-considerations-device-manufacturers https://www.fda.gov/medical-devices/products-and-medical-pro...