On 27 September 2019 the U.S. Food and Drug Administration (FDA or the agency) released the draft guidance entitled "Clinical Decision Support Software" (CDS guidance), which updates the framework for FDA's oversight of CDS products, substantially revising the draft guidance that was previously released in 2017, "Clinical and Patient Decision Support Software." FDA simultaneously issued a number of final guidance documents updating the medical software regulatory framework developed to implement the 21st Century Cures Act (Cures Act), which we discuss in a companion client update.