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MDMA Statement on Proposed Package for Medical Device User Fees

Wednesday, February 01, 2012  
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WASHINGTON, DC – Mark Leahey, President and CEO of the Medical Device Manufacturers Association (MDMA), issued the following statement today regarding the tentative agreement between FDA and industry negotiators on medical device user fees:

"The ultimate goal for all parties in the user fee negotiations is to make the necessary improvements to the device review program that will ensure patients have timely access to safe and effective products. MDMA is pleased that these discussions have resulted in proposed enhancements to the program that will lead to greater accountability, predictability and transparency.

"These enhancements include earlier interactions between FDA and industry, improvements to the pre-submission process, a new mechanism to address submissions that fall outside of the quantitative goals, enhanced reporting on performance and an independent assessment of the premarket review process. To support these improvements, industry is willing to provide FDA with $595 million in user fees over five years. These resources will result in the hiring of more than 240 device review process full-time employees. This significant investment, coupled with the program enhancements, will allow FDA to fulfill its mission to promote patient care and innovation in the coming years.

"America’s medical device industry has a long and proud tradition of improving the quality of life for patients, while creating hundreds of thousands of jobs that drive the innovation ecosystem. We believe this agreement will help support these entrepreneurial efforts, and MDMA will continue to work with policy makers, elected officials and all stakeholders so that med tech innovators can deliver on the promises of a better tomorrow.”