Upstate Medical University

RAPs Virtual Event, Digital Health: Fundamentals of FDA Regulation

There has been an explosion of digital health technologies in recent years, encompassing widespread use of computing platforms, connectivity, software, and sensors. This new technology is revolutionizing many aspects of healthcare, including artificial intelligence (AI), machine learning (ML), and mobile medical apps and software that support the clinical decisions doctors make every day. These technological advancements have significant implications for FDA regulation and — and for all regulatory professionals.

Attend this live virtual event and learn how the FDA regulates digital health, including FDA approaches to software as a medical device (SaMD), AI/ML, cybersecurity, device software functions, mobile medical applications, medical device data systems (MMDS), and general wellness devices. In addition to the pertinent FDA guidance, there will be a detailed explanation of the 2022 statutory changes requiring cybersecurity information in premarket submissions for so-called cyber devices, and permitting post-clearance change control. This event will also review the implications of the new FDA new draft guidance document on recommended software documentation for premarket submissions, the first update in more than 15 years.

Registration Fees & Deadlines

11 October  2023 - 16 December 2023: Early Bird: $150 Member | $175 NonMember
17 December 2023 – 14 February 2024: Regular: $175 Member | $200 NonMember