FDA, Device Groups Tentatively Agree To Real-World Evidence Pilot In User Fee Goals

FDA and the medical device industry appear to have smoothed out a point of contention in negotiations for the user fee reauthorization by including plans for a pilot to assess the effectiveness of real-world evidence to support premarket activities, according to statements by the agency and the industry groups outlining a tentative agreement on user fee goals. Key medical device lobby groups initially told FDA that their members opposed the agency's real-world evidence funding plan. FDA said details of the...