Senate Democrats Raise Major Concerns With FDA Software Pre-Cert Plan

Three Democratic senators wrote to top FDA officials Wednesday (Oct. 10) that they have “serious concerns” about the agency's emerging precertification program, where precertified software developers would not be subject to premarket review. In the letter, Sens. Elizabeth Warren (MA), Patty Murray (WA), and Tina Smith (MN) ask what statutory authority FDA has to establish the program; what criteria FDA will use to evaluate firms; and how FDA will continue to hold firms to standards of safety and efficacy once...