MDMA Statement on House Passage of User Fee Programs
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 Innovation Act:”
“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 effective products.”
“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.”