 
Today, the U.S. Food and Drug Administration (FDA) issued the final guidance Clinical Decision Support Software. The final guidance clarifies the scope of the FDA’s oversight of clinical decision support (CDS) software intended for health care professionals as devices. This guidance further clarifies that the FDA’s existing digital health policies continue to apply to software functions that meet the definition of a medical device, including those that are intended for use by patients or caregivers.
The FDA has developed a graphic to provide a visual overview of certain policies described in the guidance and examples of non-device CDS functions and device software functions for illustrative purposes.
The FDA is also issuing the Digital Health Policy Navigator to help stakeholders with digital health policies. This tool guides users through a series of questions based on published digital health policies, to provide general information to help a user assess whether a particular software function meets the device definition and, if so, whether it is the focus of FDA’s oversight as a device. The tool directs users to the appropriate policies to learn more.
Upcoming webinar on this guidance
On October 18, 2022, the FDA will host a webinar for industry, health care providers, and others interested in learning more about the final guidance.
Related Guidances Updates
The FDA has also issued minor updates to the following guidances:
These updates align these guidance documents with the final rule Medical Devices; Medical Device Classification Regulations To Conform to Medical Software Provisions in the 21st Century Cures Act (86 FR 20278) and the final Clinical Decision Support Software guidance.
Questions?
If you have questions about the final guidance on Clinical Decision Support Software, please email digitalhealth@fda.hhs.gov.
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