FREE ON-DEMAND WEBINAR:
December 1, 2022
FDA Digital Health Updates: What changed in 2022 and what should you expect in 2023?
With the rapid advancement of Digital Health products, FDA must ensure that their regulatory approach remains consistent across all of the OHTs (Office of Health Technology) and that their recommendations remain aligned with software development best practices.
To that end, FDA has released several new Guidance Documents for Digital Health Products, which reflect FDA’s current thinking. These regulatory changes can affect how to properly classify your Digital Health Product and how it will ultimately be regulated.
Additionally, FDA has released several new tools (e.g., eSTAR, Digital Health Policy Navigator) and informational pages that can help aid your next Digital Health regulatory submission.
Finally, FDA has proposed several cross-cutting Guidance documents in FY2023, which can greatly impact how Digital Health submissions are reviewed.
This free, in-depth webinar, presented by regulatory experts Kevin Go and Allison Komiyama, will discuss recent regulatory developments in the Digital Health space, how to apply them for a successful submission, and how to prepare for the upcoming changes.