Ensuring the safety and efficacy of artificial intelligence used in clinical decision software (CDS) and other AI-related devices is within the US Food and Drug Administration’s purview, but the agency “has not yet promulgated” any final software as a medical device (SaMD) regulations, charges a new report from the Government Accountability Office (GAO) and the National Academy of Sciences.
In the 30 November GAO/NAS report, “Artificial Intelligence in Health Care,” the GAO and the NAS acknowledged that in April 2019, the FDA did issue a proposed regulatory