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Mark E. Brager
(202) 434-7244
June 7, 2017

AdvaMed Commends House MDUFA Progress

WASHINGTON, D.C. – The Advanced Medical Technology Association (AdvaMed) issued the following statement from President and CEO Scott Whitaker on today’s mark-up in the House Energy and Commerce Committee of the FDA Reauthorization Act of 2017:

“Today’s mark-up is another significant step toward reauthorization of the Medical Device User Fee Act, and AdvaMed commends the Committee for expeditiously moving this important legislation forward.

“We are pleased that the legislation now includes language to streamline the review process for medical device accessories and thank the co-sponsors of the bipartisan bill (HR. 2144) – Reps. Mimi Walters (R-Calif.) and Ann Kuster (D-N.H.) – for their leadership on this issue.

“The negotiated agreement between FDA and industry to reauthorize MDUFA will improve the efficiency, predictability and transparency of the agency’s review processes while providing significant additional resources to FDA.

“This agreement is beneficial to patients, FDA and American innovation, and we urge the full House and Senate to vote on the FDA Reauthorization Act of 2017 as soon as possible. A failure to act would have a negative impact on our industry’s ability to bring new, innovative treatments, diagnostics and cures to patients.”