Our colleague and contributor Cassie Scherer just published a post on the InsideMedicalDevices blog analyzing today’s FDA draft guidances on the Center for Devices and Radiological Health’s (CDRH) policy regarding low risk general wellness products and regulation of medical device accessories. Although the guidances are not solely focused on software, they provide further clarification to the rapidly developing and expanding mobile app and software industry. Further analysis of the draft General Wellness Guidance can be found in our client alert, available here.