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.
Register for the webinar: Message from Greenlight Guru
Specifically, this webinar will cover:
- Understand new Guidance documents and impact on software classification
- How to find and utilize the Digital Health Policy Navigator and new informational FDA pages
- Learn benefits of using eSTAR for Digital Health submissions
- Understand which future Guidance documents are proposed in FY2023 and their impact
- How to implement current FDA thinking and best practices into your next Digital Health regulatory strategy/submission
Who should attend?
- SaMD Regulatory Professionals and Management
- Quality Professionals and Management
- Product Development Engineers and Management
- Medical Device Executives
