FDA updates guidelines on Clinical Decision Support Software and Wellness Devices

For the second time in a month, the US Food and Drug Administration (FDA) has updated its guidance on Clinical Decsion Support (CDS) Software. The Agency published its first final guidance on the subject in 2022, but then issued an updated version on 6 January 2026, which was superseded by a further version on 29 January 2026.

The FDA explains that the purpose of the guidance is to describe the Agency’s regulatory approach to CDS software functions, reflecting changes to the FD&C Act made by the Cures Act, which amended section 520 and excludes certain software functions from the device definition. The focus of the guidance is therefore to clarify the types of CDS software functions that are excluded from the definition of medical device.

For example, some decision support software functions may be identified in other FDA guidance documents as software functions for which, based on a current understanding of the risks of these software functions, FDA does not intend at this time to enforce compliance with applicable device requirements. To avoid being classified as a device, all four of the following criteria must be met:

(1) not intended to acquire, process, or analyze a medical image or a signal from an in vitro diagnostic device or a pattern or signal from a signal acquisition system;
(2) intended for the purpose of displaying, analyzing, or printing medical information about a patient or other medical information;
(3) intended for the purpose of supporting or providing recommendations to a health care professional about prevention, diagnosis, or treatment of a disease or condition; and
(4) intended for the purpose of enabling such health care professional to independently review the basis for such recommendations that such software presents so that it is not the intent that such health care professional rely primarily on any of such recommendations to make a clinical diagnosis or treatment decision regarding an individual patient.

On a similar topic, the Agency has also updated its guidance on its General Wellness Policy for Low Risk Devices, superseding its 2019 guidance. The FD&C Act, states that software that is intended “for maintaining or encouraging a healthy lifestyle and is unrelated to the diagnosis, cure, mitigation, prevention, or treatment of a disease or condition” is not a device under section 201(h) of the Act. FDA explains that the guidance clarifies its interpretation of this provision and its application to general wellness products.

For purposes of the guidance, FDA defines general wellness products as products that meet the following two factors: (1) are intended for only general wellness use, as defined in the guidance, and (2) present a low risk to the safety of users and other persons.