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The purpose of this video is to: 1) Provide an Overview of FDAs Software Precertification Pilot Program, or Pre-Cert; 2) Explore how FDA is developing Pre-Cert; and 3) Explain how FDA Envisions Pre-Cert Could Work. With that in mind, lets get started. From mobile medical apps and software that support the clinical decisions doctors make every day to artificial intelligence and machine learning, digital technology has been driving a revolution in health care. The FDA plays a critical role in assuring that when these technologies are used for medical purposes, they are safe and effective, so people feel confident using them. Software as a Medical Device, or SaMD, is one type of digital health technology. SaMDs are software that take information from medical devices, wearables, or other sources to perform medical functions. SaMDs can have a wide range of medical functions, including informing or driving clinical management, as well as assisting health care providers in diagnosing or tre