This panel will discuss FDA's new Digital Health Center of Excellence, and how FDA envisions enabling to utilization of software in the medical health ecosystem. For example, Software-as-a-medical device (SaMD) is an emerging component of the healthcare continuum, and the ubiquitous proliferation of smart phones means that we have an additional mechanism for engaging patients and improving patient outcomes. The agile nature of software makes the process novel for both health authorities and software developers, especially when the software in regulated as a medical device. A regulatory approach that provides for updating and refining software while maintaining patient safety, clarity of effectiveness, labeling and reliability, is needed. Evaluating needs versus current paradigms is important. This session will discuss the current state, gaps, and discuss plans for future consideration, especially as it related to developing regulatory approaches for software devices in the United States, including novel approaches to regulating devices that incorporate artificial intelligence and machine learning, clinical decision support software that is not regulated, and FDA's Precert Program.