Digital Health Update: The FDA Issues Software-Related Guidance Documents

BAs part of the long-term Digital Health Innovation Action Plan and in response to stakeholder feedback on draft guidances, today, the U.S. Food and Drug Administration (FDA) is issuing a draft guidance, issuing a final guidance, and updating four existing final guidances to clarify the FDA’s digital health policy, per the 21st Century Cures Act. Draft Guidance  The FDA is issuing a draft guidance titled Clinical Decision Support Software to describe the FDA’s regulatory approach to clinical decision support software functions. This new draft guidance includes changes made in response to public comments received on the 2017 draft guidance on this topic (originally titled Clinical and Patient Decision Support Software).  Submit Comments on Reissued Draft Guidance  The Clinical Decision Support Software draft guidance will be open for public comments for 90 days at www.regulations.gov under docket number FDA-2017-D-6569.

Submit Comments Final Guidances In addition, the FDA is issuing a final guidance, Changes to Existing Medical Software Policies Resulting from Section 3060 of the 21st Century Cures Act. This guidance details the changes to existing guidance documents that relate to the regulation of the software functions. As such, the FDA updated the following final guidances to ensure consistent policy in the regulation of digital health products:  Policy for Device Software Functions and Mobile Medical Applications (originally titled Mobile Medical Applications) General Wellness: Policy for Low Risk Devices Off-The-Shelf Software Use in Medical Devices Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communications Devices Upcoming Webinar Series The FDA will host a webinar series for industry and others interested in learning more about these software-related guidances: November 4: Clinical Decision Support Software draft guidance November 14: Changes to Existing Medical Software Policies Resulting from Section 3060 of the 21st Century Cures Act final guidance as well as the four related final guidance documents listed above.  Read More Questions? If you have questions about these guidance documents, email digitalhealth@fda.hhs.gov.