Duke Report: Real-World Data Pilots Must Gain Buy-In From Device Makers

The planning board for FDA's proposed real-world evidence system for medical devices has identified potential pilot programs it says are essential for gaining buy-in from industry, which has been reluctant to fund the new initiative beyond a five-year pilot. FDA recently announced the Medical Device Innovation Consortium would be the program's coordinating center and receive $33 million dollars over five years from a combination of FDA funding and user fees. The board says initial pilots should focus on balancing premarket...