On January 6, the Food and Drug Administration (FDA) updated its guidance documents on Clinical Decision Support (CDS) software and general wellness products, and withdrew its guidance on the adoption of international principles for Software as a Medical Device (SaMD): Clinical Evaluation. FDA’s policy changes lean toward a more deregulatory approach to digital health, including enforcement discretion for certain prediction software, and exemption of certain wearables with non-invasive monitoring from FDA regulation.
Clinical Decision Support (CDS) Software
FDA updated its guidance on CDS, last revised in 2022, which clarifies FDA’s thinking on the types of CDS functions that are excluded from the definition of device by the criteria specified by the 21st Century Cures Act.
Among other changes, FDA deviates from prior guidance by providing that it will not enforce FDA regulatory requirements for software functions that otherwise meet the exclusion criteria under the 21st Century Cures Act, but which produce only one clinically appropriate treatment option or recommendation.
Clinical Decision Support (CDS) Software
FDA updated its guidance on CDS, last revised in 2022, which clarifies FDA’s thinking on the types of CDS functions that are excluded from the definition of device by the criteria specified by the 21st Century Cures Act.
Among other changes, FDA deviates from prior guidance by providing that it will not enforce FDA regulatory requirements for software functions that otherwise meet the exclusion criteria under the 21st Century Cures Act, but which produce only one clinically appropriate treatment option or recommendation.
