Section 3060(a) of the 21st Century Cures Act (Cures Act), enacted on December 13, 2016, amended section 520 of the Federal Food, Drug & Cosmetic Act (FD&C Act) to exclude certain medical software functions, including certain decision support software, from the definition of device under section 201(h) of the FD&C Act. Based on comments received on the September 2019 Draft Guidance, this final guidance clarifies FDA’s thinking expressed in the September 2019 Draft Guidance and focuses on clarifying the types of clinical decision support (CDS) software functions that are excluded from the definition of device by the criteria in section 520(o)(1)(E) of the FD&C Act (“Non-Device CDS criteria”).


The final guidance further clarifies that FDA’s existing digital health policies continue to apply to software functions that meet the definition of a device, including those that are intended for use by patients or caregivers. Additionally, the final guidance provides examples of how FDA applies the Non-Device CDS criteria. These examples identify Non-Device CDS functions that meet all four criteria and device functions that do not meet one or more of the criteria.