This document supersedes “Clinical Decision Support Software” issued on January 6, 2026.
The Food and Drug Administration (FDA) has long regulated software that meets the definition of a device in section 201(h) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), including software that is intended to provide decision support for the diagnosis, treatment, prevention, cure, or mitigation of diseases or other conditions (often referred to as clinical decision support software).
This guidance clarifies the scope of FDA’s oversight of clinical decision support software intended for health care professionals (HCPs) as devices. Not all clinical decision support software used in healthcare settings are devices and therefore subject to FDA oversight as a device.