Fundamentals of Digital Health Regulation: Successfully Navigating Your Product Through FDA
February 25, 2025 | Virtual Course
Overview
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. In this course, you’ll learn whether and how these categories of products are regulated as medical devices. Then, 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. Finally, the course will 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 Digital Health Technology and Regulation Conference.
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Early registration expires 1/31/2025
Add This Must-Have Reference to Your Registration
Purchase A Practical Guide to FDA’s Food and Drug Law Regulation, 7th Edition to have an overview of the key legal and regulatory topics at your fingertips. Order your copy today and it will be shipped directly to your office.
