FDA Updates Digital Health Guidances to Align with 21st Century Cures Act
Source https://www.mintz.com/insights-center/viewpoints/2791/2019-10-fda-updates-digital-health-guidances-align-21st-century On September 26, 2019, FDA released a suite of revised digital health guidances, which includes the following: Changes to Existing Medical Software Policies Resulting from Section 3060 of the 21st Century Cures Act (“Section 3060 Changes Guidance”) – Final Policy for Device Software Functions and Mobile Medical Applications (“MMA Guidance”) – Final General Wellness: Policy for