WASHINGTON, D.C. – The Advanced Medical Technology Association (AdvaMed), the world’s largest trade organization representing medical technology device developers and manufacturers, welcomes the opportunity to testify before a key congressional committee on the fifth reauthorization of the Medical Device User Fee Amendments (MDUFA).

“Our society stands at the edge of a Golden Age of medical technology,” said Scott Whitaker, AdvaMed president and CEO. “Congress, industry and the Food and Drug Administration must step into this bold new world of patient treatments and cures together. The agreement before lawmakers sets up the FDA to receive the support it needs to maintain its unparalleled review standards and help deliver the highest quality medical devices to the American people. AdvaMed is grateful for the opportunity to testify on this historic agreement.”

“Our society stands at the edge of a Golden Age of medical technology.” 

––Scott Whitaker, President & CEO, AdvaMed  

The first congressional hearing on the reauthorization this year is scheduled for Wednesday. The U.S. House of Representatives Energy and Commerce Health Subcommittee will hear from witnesses including Janet Trunzo, AdvaMed’s senior executive vice president, Technology and Regulatory Affairs. The medical technology industry and the FDA negotiated the MDUFA V agreement before Congress, achieving several firsts for performance metrics and greater communication. Excerpts from Trunzo’s prepared testimony:

“We approached this reauthorization with the same two overarching principles we have had in the past: Patients must continue to benefit from access to safe and effective devices; and the user fee program and its associated goals should be refined and improved. We also recognized that the COVID-19 public health emergency had required a significant effort by FDA, and in particular by the Device Center, given the hundreds of Emergency Use Authorizations submitted and issued for diagnostic tests, ventilators, and personal protective equipment, and other devices that were critical to the nation’s response to COVID-19.”

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“We expect to see improvements in review times compared to MDUFA IV goals or compared to current performance, depending on the particular submission type. For the first time, however, we have developed a structure that would allow for enhanced goals, and funding to support those goals, based on FDA’s performance during the five-year cycle.”

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“The package provides significant additional resources to ensure that FDA can provide timely feedback to companies seeking pre-submission guidance from the agency.”

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“This package will fund targeted initiatives to support the premarket review program.”

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“This package contains specific performance measures for and evaluation of the program as a whole by funding a quality management program and two independent assessments of aspects of the program and targets for hiring using MDUFA funds.”

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“Overall, this recommended package will support, in addition to continuing to fund the base MDUFA funding, an estimated minimum of 273 new FTEs (full-time equivalents) to support the process for device review, with the potential of up to 387 FTEs based on meeting the enhanced goal targets.”

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“This structure provides ample support to the agency to deliver on the commitments in the MDUFA V commitment letter (from the FDA) and to continue to ensure that patients in the United States have access to the most cutting edge, safe and effective medical devices.”

Also, Whitaker outlined the importance of the agreement in an op-ed for Medtech Insight.

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AdvaMed member companies produce the medical devices, diagnostic products and health information systems that are transforming health care through earlier disease detection, less invasive procedures and more effective treatments. AdvaMed members range from the largest to the smallest medical technology innovators and companies. For more information, visit www.advamed.org.