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Mark E. Brager
May 2, 2017

AdvaMed Statement on House Medical Device Policies 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 additional medical device policies to be considered as part of the FDA Reauthorization Act of 2017:

“AdvaMed would like to thank the members of the Subcommittee for holding today’s hearing. The additional medical device bills being discussed today will further strengthen an already strong agreement to reauthorize the Medical Device User Fee Act. We also would like to thank Pat Shrader, VP of Global Regulatory Affairs, Medtronic, for testifying on behalf of the association.

“We are particularly pleased today’s hearing will address bipartisan legislation (HR. 1736) to improve the consistency, predictability and transparency of FDA’s medical device inspections process. We commend the original sponsors of this legislation – Reps. Larry Buschon (R-Ind.), Scott Peters (D-Calif.), Susan Brooks (R-Ind.) and G.K. Butterfield (D-N.C.) – for their leadership on this issue.

“AdvaMed is also supportive of legislation (HR. 2118) requiring registration of servicers of medical devices. As the MDUFA reauthorization process moves forward, we hope Congress will consider other measures to further enhance the legislation, such as the bipartisan bill (HR. 2144) recently introduced by Reps. Mimi Walters (R-Calif.) and Ann Kuster (D-N.H.) to streamline the review process for medical device accessories.

“We look forward to working with Congress on these important issues.”

A copy of Ms. Shrader’s written testimony is available here.