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Senate Committee Completes Work on User Fees

Thursday, September 12, 2013  
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The Senate HELP Committee marked-up legislation incorporating the various user fees today, including MDUFA. The committee rejected certain amendments that were offered to alter the bill, which highlighted several issues that Members of Congress continue to focus on related to medical device regulations.

MDMA sent a letter to the Committee thanking them for all of their work on this important legislation, and also to highlight concerns as we all move forward.

"We believe that both the user-fee proposal and the accompanying legislative reforms are steps in the right direction to ensure that patients are provided timely access to safe and effective products," wrote Mark Leahey, President and CEO of MDMA. "MDMA would like to reiterate our concerns related to the reclassification proposal and look forward to continued discussions with the Committee to ensure that the proposal does not limit the ability or impact of stakeholder comments during the process."

The House Energy and Commerce Committee is expected to take up their version of the legislation on May 8, 2012, and MDMA will continue to work with Members of Congress to ensure the final language supports medical technology innovation.