Senate Committee Completes Work on User Fees
Thursday, September 12, 2013
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.
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.