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Mark E. Brager
March 28, 2017

AdvaMed Statement on House Medical Device User Fee Hearing

WASHINGTON, D.C. – The Advanced Medical Technology Association (AdvaMed) issued the following statement from President and CEO Scott Whitaker on today’s hearing in the House Energy and Commerce Health Subcommittee on reauthorization of the Medical Device User Fee Act (MDUFA):

“AdvaMed would like to thank the members of the Subcommittee for holding today’s hearing. Reauthorization of MDUFA is crucial for improving patient care and fostering American medical innovation. We also would like to thank AdvaMed Accel Board Chairman Patrick Daly, president and CEO of Cohera Medical, for testifying on behalf of the association.

“The new MDUFA package is a win-win-win for FDA, for innovation and, most of all, for patients. The user fee agreement negotiated between industry and the agency lays the groundwork for further FDA performance improvements – building on the success of the current MDUFA – through more ambitious performance goals, important process changes, and increased accountability, supported by significant additional resources.

“We look forward to working with Congress to move this legislation forward and urge both chambers to act promptly to reauthorize the user fee program and enact this agreement into law.

“Failure to act could jeopardize the opportunity to improve the efficiency and predictability of FDA’s review process for medical technology which would negatively impact our industry’s ability to bring innovative diagnostics, treatments and cures to patients.”

A copy of Mr. Daly’s written testimony is available here.