Guidances with Digital Health Content
The guidance documents listed here are FDA guidances with Digital Health content and are intended to provide clarity on the FDA's regulation of digital health products.
List of FDA Guidance Documents with Digital Health Content
Resources
- Webinar Materials - Changes to Existing Medical Software Policies Resulting from Section 3060 of the 21st Century Cures Act: Final Guidance (2019)
- Webinar – Clinical Decision Support Software Final Guidance (2022) - The presentation, printable slides, and transcript are available at CDRH Learn under "Specialty Technical Topics", sub-section "Digital Health."