The U.S. Food and Drug Administration (FDA) and the medical device industry came to an agreement about the proposed fifth iteration of the medical device user fee amendments (MDUFA V). Details about MDUFA V have been made public.
 
Under the new program, the FDA would be authorized to collect at least $1.78 billion in user fees over five years, plus further funding, totaling up to $1.9 billion if specified goals are met. FDA said the funding would offer integral resources to its medical device review program.
 
FDA published the proposed MDUFA V recommendations to its website. They will also be published in the Federal Register for public comment.
 
The agency will hold a virtual MDUFA V public meeting on April 19 so the public can learn more about it and offer their views. Final recommendations are scheduled for delivery to Congress in April after FDA considers the public input and revises 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,” Jeffrey Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health told the press. “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.”
 
“This agreement in principle represents a significant investment in the MDUFA program,” added Medical Device Manufacturers Association (MDMA) president and CEO Mark Leahey. “MDMA appreciates FDA’s dedication and efforts during the COVID-19 pandemic, and we are confident the agency will effectively leverage the additional resources to accelerate patient access to safe and effective medical technologies. MDMA looks forward to working with Congress to reauthorize MDUFA.”