FDA publishes guidance Q&A on Clinical Support Software

The US Food and Drug Administration has recently published a Q&A document on the subject of Clinical Support Software, following release of full guidance on the topic in January 2026.

The Q&A explains that “Clinical Decision Support (CDS) software are important tools in modern health care. While some CDS software has been excluded from the definition of a medical device by the 21st Century Cures Act (Cures Act), many software functions continue to meet the definition of a medical device and are the focus of the Food and Drug Administration’s (FDA) regulatory oversight. Because a wide variety of software can be described as “decision support,” understanding the regulatory requirements that may apply to such software can be challenging”.

The Q&A lists seven questions and answers, commenting that: “These FAQs are intended to help sponsors identify whether their CDS software may or may not meet the definition of a device and provide additional resources specifically to those developing CDS software tools”.