Upcoming Events
Fundamentals of Digital Health Regulation: Successfully Navigating Your Product Through FDA
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.
February 25, 2025 | Virtual Course
Register by 1/31/25 and SAVE
Fundamentals of Digital Health Regulation: Successfully Navigating Your Product Through FDA
register now
February 26–27, 2025 | Virtual Event
Register by 1/31/25 and SAVE
Digital Health Technology and Regulation Conference
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Essentials of Working with FDA for Patient Organizations
Please join us for this reimagined, complimentary two-day training program, where FDLI brings together law, industry, and FDA experts with deep expertise to equip patient advocates and organizations with an understanding of the legal tools and strategies available for interacting with the agency. In this complimentary course, participants gain insight into FDA’s regulatory processes and learn practical tactics for engaging with CBER, CDER, CDRH, the Rare Disease Innovation Hub, and other FDA offices.
March 4–5, 2025 | In-Person & Virtual Course
For 501(c)(3) Patient or Disease Organizations Only
Essentials of Working with FDA for Patient Organizations
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Introduction to Food Law and Regulation
Explore the essentials of food law and regulation and gain a comprehensive understanding of the various administrative agencies that impact these industries. Learn about pending regulations, food safety, food labeling, enforcement, and related issues. Case studies, hypotheticals, and ample time for discussion are provided.
March 11–12, 2025 | Virtual Course
Register by 1/31/25 and SAVE
