FDA finalises guidance on clinical decision support (CDS) software

The US Food and Drug Administration has published the final version of its guidance document ‘Clinical Decision Support Software – Guidance for Industry and Food and Drug Administration Staff’, available from here.

Three years have passed since the Agency issued a draft of the document, to which many comments were received as a result of the subsequent public consultation.

The Agency’s approach in the final version reflects changes to the FD&C Act made by the Cures Act, which excluded certain software functions from the device definition.

The Agency explains that the focus of the guidance is to clarify the types of CDS that are excluded from the definition of device as a result of the Cures Act and provides many examples of how different kinds of software functions, including Non-Device CDS software functions and device software functions, will in future be considered by FDA.