Unpacking FDA's Final Clinical Decision Support Guidance

On Sept. 28, the U.S. Food and Drug Administration published the final version of its clinical decision support software guidance, implementing statutory changes made by the 21st Century Cures Act of 2016.

The guidance describes the agency's interpretation of the criteria for clinical decision support software functions excluded from device regulation under Section 520(o)(1)(E) of the Federal Food, Drug and Cosmetic Act.

The guidance had been eagerly awaited by industry, as the FDA's prior 2019 draft guidance had left open many interpretive questions. While there is a lot to unpack in the final guidance, it introduces new concepts, questions and ambiguities and may be challenging to implement in practice.