Sens. Elizabeth Warren (D-Mass.) and Patty Murray (D-Wash.) voiced concern in a letter to the FDA that the agency is planning to loosen medical device regulations through provisional approvals.
The letter to acting FDA Commissioner Ned Sharpless and CDRH director Jeff Shuren raises alarms over language in the agency’s FY 2020 budget that recommends “progressive approval for devices.”
The proposal would allow certain devices to initially gain a pending approval based on showing safety and performance and remain on the market after demonstrating “reasonable assurance of safety and effectiveness.”
The lawmakers noted that former FDA Commission Scott Gottlieb had voiced his disapproval for expanding conditional approval pathways to include human medical products and asked the agency to clarify if that is its intention.