Reimagining the FDA’s Role in Digital Medicine

The FDA should allocate more resources to assessing the efficacy and quality of software as a medical device (SaMD), on top of its safety evaluations. The call comes after a review of approvals found most were based on retrospective studies, with none of the high-risk devices assessed by prospective trials. Mayo Clinic is considering a more holistic approach to evaluating SaMD, involving a standard labelling schema documenting system characteristics, intended use and performance measures.