MDMA Statement on House Passage of User Fee Programs
Wednesday, June 20, 2012
WASHINGTON, DC – Mark Leahey, President and CEO of
the Medical Device Manufacturers Association (MDMA), issued the
following statement today regarding the U.S. House of Representatives
passage of S. 3187, the "Food and Drug Administration Safety and
"This final legislation represents a strong vision for
medical technology innovation over the coming years, and addresses many
of the challenges that face our dynamic industry.
"It became abundantly clear during the course of negotiations
and passage of this legislation that Congress and numerous stakeholders
recognized just how important it is for the United States to retain our
global leadership position in medical technology. A transparent and
reasonable regulatory process is the key to accomplishing this goal.
"The final language establishes powerful tools and milestones
to help ensure that FDA is able to fulfill its dual mission of
protecting patients and advancing innovation. This includes a more
reasonable IDE process and strengthening the least burdensome doctrine.
FDA's consistent execution and implementation of the key reforms in
this legislation and the accompanying Commitment Letter will be critical
in making sure that American patients have timely access to safe and
"MDMA thanks the chairmen and ranking members of the
respective committees who advanced this important legislation, and
showed how bipartisan efforts can benefit patients and innovators.
"MDMA will continue to work closely with FDA and Members of
Congress so that all the hard work that went into reauthorizing user
fees results in a more efficient regulatory system. Patients and
providers are counting on us to realize the goals we have established,
and America’s medical technology innovators are ready to do their part.”