Guidance on Clinical Decision Support: Definitions and Transparency

The new FDA draft guidance for clinical decision support software is an important step forward but still has a long way to go.

Roughly two years after we reviewed the first FDA guidance on Clinical Decision Support (CDS), FDA issued new draft guidance. The FDA was criticized for not basing their first draft regulation criteria on use-case risk. Since then the International Medical Device Regulators Forum (IMDRF), which the FDA chaired, created a framework for organizing Software as a Medical Device (SaMD) by risk categories. While CDS is a very broad category that encompasses many functions, this guidance could have an outsize impact on the need to provide transparency in AI/ML platforms and algorithms for healthcare.