Medtech Insight

FDA Publishes Final Guidance On Clinical Decision Support Software, Clarifies What Software Should Be Regulated As Medical Devices

29 Sep 2022

In its final document, the US FDA outlines its interpretations of the four criteria for excluding clinical decision support software from being regulated as medical devices under federal law. Software must meet all four criteria to be excluded.

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After three years in the making, the US Food and Drug Administration has published final guidance that clarifies the agency’s approach to regulating clinical decision support (CDS) software as medical devices.

The FDA regulates software as medical devices in some, but not all, cases.