FDA Statement on Medical Device User Fee Amendments (MDUFA)

The FDA and representatives from the medical device industry have reached an agreement on proposed recommendations for the fifth reauthorization of the medical device user fee program. Under the new agreement, the 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. This funding would provide critical resources to the FDA medical device review program. The proposed recommendations have been posted on our website and will be published in the Federal Register for public comment. Additionally, the MDUFA V public meeting will be held virtually April 19, 2022, to provide the public an opportunity to learn more about and provide their views on the proposed recommendations. The final recommendations are 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, M.D., 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.”

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