U.S. FDA REGULATORY GUIDELINES AND VALIDATION OF DIGITAL THERAPEUTICS

Digital therapeutics (DTx) are evidence-based, software-driven interventions intended to prevent, manage, or treat diseases and medical conditions. Their increasing use in mental health, neurological disorders, substance-use disorders, chronic diseases, and behavioral medicine has created a need for regulatory frameworks that address clinical effectiveness, software reliability, cybersecurity, usability, and continuous technological change. In the United States, DTx that meet the statutory definition of a medical device are principally regulated by the U.S. Food and Drug Administration (FDA) within the device software framework. Regulatory requirements depend on intended use, risk, technological characteristics, and device classification, with 510(k) premarket notification, De Novo classification, and Premarket Approval (PMA) representing the major premarket routes.