FDA Finally Releases MDUFA V Details

Details surrounding the proposed fifth iteration of the medical device user fee amendments (MUDFA V) have been made public.

Under the proposed measure, FDA would be authorized to collect at least $1.78 billion in user fees over five years, plus additional funding, for a total of up to $1.9 billion to further improve performance if specified goals are met. FDA said this funding would provide critical resources to its medical device review program. 

FDA will now hold a virtual public meeting April 19 to provide comments. The final recommendations are then scheduled to be delivered to Congress in April 2022, after FDA considers public input on the proposed recommendations and revises them as necessary. 

“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, J.D., 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.”

AdvaMed, one of the largest advocacy agencies for the medical device industry, spoke positively about the proposed measure.

“The medtech industry is poised to unleash a whole new dimension of innovation for patients in the coming years,” AdvaMed’s president Scott Whitaker said in prepared remarks. “Technology is making possible what once seemed impossible. This historic agreement connects increased industry user fees to FDA performance for the first time. It holds innovators to high standards for communicating device performance to the agency. The result will be more timely approval of medical technology earning the FDA’s global gold standard of safety and effectiveness. AdvaMed looks forward to public and congressional consideration of the agreement. The future of life-saving, life-enhancing medical technology for patients is brighter than ever under this vision.”