New agreement on user fees for medical devices passes Congress

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The U.S. Congress today sent an interim funding bill to President Joe Biden’s office that includes reauthorizing the FDA’s user fee programs through 2027.

“I am pleased to say that Congress has passed legislation reauthorizing the four user fee programs that provide critical funding to the FDA for its human medical products business,” said FDA Commissioner Dr. Califf on Twitter.

Later, he tweeted, “This means we won’t need to start the notification process for staff funded by user fees.”

The reauthorization generally maintains the existing fee structure, but includes a new mechanism through which the FDA can increase fees in subsequent years if it meets targets related to timely review of submissions.

Trade group AdvaMed also applauded the passage of the fifth version of the Medical Device User Fees Amendment (MDUFA V).

“The bipartisan passage of this landmark five-year agreement ushers in a new era of healthcare innovation, ensuring greater predictability, consistency, accountability, and communication between the FDA and changing medical technology innovators. the way patients seek out and receive life-saving care.We are in a golden age of innovation in medical technology, and the improvements brought about by MDUFA V will serve as a catalyst for even greater transformations of healthcare,” AdvaMed CEO Scott Whitaker said in a press release.

Medical Device Manufacturers Association CEO Mark Leahey said, “While more work needs to be done to strengthen our nation’s leadership in medical technology innovation, this legislation represents an important investment. in the MDUFA program, and MDMA remains confident that the FDA will effectively leverage additional resources to accelerate patient access to safe and effective medical technologies.

The reauthorization that passed left out additional Senate proposals. Said Califf: “While the user fee reauthorization package passed by Congress does not include additional policy changes that we believe would benefit public health, we remain committed to working with Congress on these policies.”


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