Cassidy Skeptical Of FDA’s Approach To CDS Software Regulation

The top Republican on the Senate health committee is criticizing FDA’s approach to regulating clinical decision support (CDS) software, asking the agency for more information about how it crafted its guidance on the technology and whether it has documentation of threats posed to patients. Sen. Bill Cassidy (R-LA), the ranking Republican on the Senate Health, Education, Labor and Pensions Committee, wrote in a letter to FDA Commissioner Robert Califf that FDA’s guidance classifying some CDS software as medical devices subjects...