Under the proposed recommendations, the agency could collect up to $1.9 billion in user fees and additional funding to further improve its medical device review program if specified goals are met. It is the fifth reauthorization of the medical device user fee program.
“The agreement underscores the continued commitment by the FDA and medical device industry to prioritize innovation and increase patient access to safe and effective medical devices,” said Jeffrey Shuren, MD, director of the FDA’s Center for Devices and Radiological Health.
“In addition, MDUFA V represents a substantial investment in the future of the agency’s medical device program and would provide for important improvements, including new hiring targets, greater engagement with developers of innovative technologies based on lessons learned from the pandemic, broadened international harmonization efforts and expanded opportunities to ensure patient perspectives are an integral part of medical device development,” Dr. Shuren said.
Read the full proposed recommendations here.
