FDA, Device Industry At Odds On Key Issues In Talks On Next User Fee Law

FDA and the medical device industry continue to disagree on key issues as discussions continue on how to craft the next device user fee law, according to minutes of an April 27 meeting between the parties. Use of real-word evidence for premarket decision-making, a high priority for FDA, remains a point of contention as industry representatives want to see the policy's tangible benefits in making the premarket process more efficient before providing a resource estimate for the proposal. Members of...