This short course will focus on how digital health technologies are being developed and regulated in the pharmaceutical/combination products space. Although many digital health technologies follow a fairly straightforward regulatory path as devices, those that interact with drug products often encounter more regulatory uncertainty. FDA’s policy on how mobile medical apps, clinical decision support software, and wearables can be combined with pharmaceutical use is still in development, so it is often difficult to navigate the regulatory path to market for these products. This course will look at currently available FDA guidances and what they mean for digital health products that combine both a drug and device. Participants will explore how to work with FDA when developing digital health technologies that may veer outside of established regulatory pathways, and a series of case studies will examine how innovators have addressed development and regulatory hurdles.
At the conclusion of this short course, participants should be able to:
- Describe how digital health technologies are being regulated by FDA through a discussion of current FDA guidances and their effect on the development and approval of digital health products, some of which combine both a drug and device
- Identify how to work with FDA when developing digital health technologies via established regulatory pathways and what to do when those technologies veer outside of established regulatory pathways
- Review specific software validation requirements, cGMPs, risk management, and cybersecurity as well as identify techniques that innovators use to address them