FDA Issues Draft Guidances Outlining Digital Health and Decision Support Software Regulatory Approaches


FDA has described its evolving approach to regulating digital health and decision support software in two new draft guidance documents:  Clinical and Patient Decision Support Software and Changes to Existing Medical Software Policies Resulting From Section 3060 of the 21st Century Cures Act.  These draft guidances announce the agency’s initial interpretation of the health software provisions enacted as part of last year’s 21st Century Cures Act and describe which digital health technologies FDA will regulate as “devices.”

Our alert discusses key takeaways from the draft guidances and implications for digital health technologies, including clinical decision support and patient decision support software, technologies that incorporate machine learning or AI, and digital health products marketed by pharmaceutical companies.

Here are a few noteworthy items from the draft guidance documents:

As discussed in our alert, companies who are marketing or developing digital health products should assess how FDA’s proposed policies may impact their product portfolio and consider submitting comments on the draft guidances.  The FDA docket is open for comments until February 6, 2018.


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National Law Review, Volume VII, Number 355