Two senators pressed acting FDA Commissioner Brett Giroir and CDRH Director Jeffrey Shuren in a Nov. 4 letter on the agency’s proposal to create a “progressive approval” pathway for medical devices.
Sens. Elizabeth Warren (D-Mass.) and Patty Murray (D-Wash.) noted former FDA Commissioner Scott Gottlieb had said in July 2018 that the agency’s conditional approval pathway for animal products would not be appropriate for human medical products.
The pathway, which the agency proposed in April, would “allow certain medical devices onto the market before manufacturers completely demonstrated the device’s safety and effectiveness,” potentially creating risks for American consumers, the senators said.