On September 27, 2022, FDA released a final guidance document titled Clinical Decision Support Software, Guidance for Industry and Food and Drug Administration Staff (“Final Guidance”), which focuses on clarifying the categories of clinical decision support (CDS) software functions that are excluded from the definition of a medical device under the criteria listed in section 520(o)(1)(E) of the Federal Food, Drug, and Cosmetic Act (FD&C Act).

This guidance finalizes the draft Clinical Decision Support Software guidance issued on September 27, 2019 (“Draft Guidance”). Given the growing use and reliance upon CDS in health care practice and delivery, this Final Guidance is particularly relevant for both software developers and health care systems and providers.