Digital health, including software, mobile health applications, machine learning and artificial intelligence (AI), wearables, and personalized medicine, has created opportunities to improve patient health and provider efficiency. This course will explore the essentials of FDA regulation of innovative medical device technologies. After a brief foray into whether and how these categories of products are regulated as medical devices, the course will cover the various regulatory pathway options for getting a technologically-focused product on the market, current FDA premarket review initiatives, AI/machine learning regulations, and cybersecurity considerations. The course will then explore post-marketing and advertising considerations. Throughout the course, there will be ample time for Q&A and discussion.
This course provides a foundation for understanding the topics that will be discussed at a more advanced level during the Current Developments in Digital Health Technology and Regulation Conference.