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.

Watch the webinar

GG_RQM+ Webinar 12-1-22
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
Register Now  

Hosted by

Etienne Nichols

Medical Device Guru & Community Manager,
Greenlight Guru

Allison Komiyama-1
Allison Komiyama, Ph.D., RAC

Vice President, MedTech Innovations,

Kevin Go (1)
Kevin Go

Senior Principal,

RQM+ Logo

About RQM+

RQM+ is the leading MedTech service provider with the world’s largest global team of regulatory and quality experts. They deliver transformative solutions to customers by providing unrivaled collective knowledge and expertise, fueled by our passion for customer success. Their experts are collaborative, laser-focused on customer needs, and committed to delivering high-value solutions for both medical devices and diagnostics that exceed expectations. Visit their website to learn more.



About Greenlight Guru

Greenlight Guru is the leading cloud-based platform purpose-built for MedTech companies. The end-to-end solution goes beyond traditional QMS needs by integrating cross-functional teams, processes, and data throughout the entire product lifecycle so device makers can proactively overcome execution gaps, streamline compliance, and accelerate market success. Greenlight Guru’s platform is used by organizations across the globe that are replacing their disjointed, legacy tools and solutions to bring life-changing products to people faster, and with less risk. Visit our homepage to learn more.

Featured In