FDA Releases Digital Health Guidances

The U.S. Food and Drug Administration released a suite of “Digital Health” guidances.

The guidances issued today are a continuation of the Agencies efforts announced as part of the Digital Health Innovation Action Plan and address key provisions of the 21st Century Cures Act.

The first guidance announced is Clinical Decision Support Software, a revised draft guidance based on public comments received on the previous draft published in 2017.

Also issued today, a final guidance Changes to Existing Medical Software Policies Resulting from Section 3060 of the 21st Century Cures Act which addresses other digital health provisions included in the Cures Act.

In addition, the Agency is updating four previously issued FDA final guidances to align with interpretations and policies under the Cures Act:

  • Final Guidance on Policy for Device Software Functions and Mobile Medical Applications
  • Final Guidance on General Wellness: Policy for Low Risk Devices
  • Final Guidance on Off-The-Shelf Software Use in Medical Devices
  • Final Guidance on Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communications Devices.

Read more at the FDA press release:  https://www.fda.gov/news-events/press-announcements/statement-new-steps-advance-digital-health-policies-encourage-innovation-and-enable-efficient-and?utm_campaign=092619_Statement_FDA%20Statement%20on%20new%20steps%20to%20advance%20digital%20health%20policies&utm_medium=email&utm_source=Eloqua

About the author

John is a 25 year FDA veteran. John served as a regulatory and compliance expert for FDA regulated computers and software. Practice (focus) areas include FDA software related guidances, software device classification determination, pre-market software review, post market software inspectional 483’s, additional information software requests, Digital Health Pre-certification, AAMI Software related TIRs and related medical device software standards.

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