New FDA Digital Health Final Guidances Signaling Deregulatory Approach: General Wellness Devices, CDS Software

This CLE webinar will provide a comprehensive overview of two recently released U.S. Food and Drug Administration (FDA) guidance documents—General Wellness: Policy for Low Risk Devices (General Wellness) and Clinical Decision Support Software (CDS)—signaling a more deregulatory approach by the agency toward digital health. The panel will examine the agency's guidance that aims to clarify distinctions between regulated and non-regulated devices, including offering clearer examples that take into account recent technological advances, and offer best practices for compliance.