The US Food and Drug Administration’s TEMPO Pilot Signals a New Regulatory Approach for AI-Enabled Medical Devices

Abstract As the pace of evolution and nature of AI-based technologies outgrow traditional frameworks for evaluation, regulatory bodies are developing new models to keep up. In this News and Perspectives article, JMIR Correspondent Tejas Athni reports on the US Food and Drug Administration’s (FDA’s) new Technology-Enabled Meaningful Patient Outcomes (TEMPO) pilot for AI-enabled medical devices.