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.

Covington Digital Health Team

Stakeholders across the healthcare, technology and communications industries seek to harness the power of data and information technology to improve the effectiveness and efficiency of their products, solutions and services, create new and cutting-edge innovations, and achieve better outcomes for patients. Partnering with…

Stakeholders across the healthcare, technology and communications industries seek to harness the power of data and information technology to improve the effectiveness and efficiency of their products, solutions and services, create new and cutting-edge innovations, and achieve better outcomes for patients. Partnering with lawyers who understand how the regulatory, IP, and commercial pieces of the digital health puzzle fit together is essential. Covington offers unsurpassed breadth and depth of expertise and experience concerning the legal, regulatory, and policy issues that affect digital health products and services. To learn more, click here.