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MDMA Statement on Booz Allen Hamilton’s Final Independent Assessment Report

Wednesday, June 11, 2014  
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WASHINGTON, DC –Mark Leahey, President and CEO of the Medical Device Manufacturers Association (MDMA), issued the following statement regarding Booz Allen Hamilton’s final report on FDA’s medical device review process.  The Independent Assessment comes as a part of the Medical Device User Fee Act of 2012 (MDUFA III).


“MDMA appreciates the diligent work by Booz Allen Hamilton to lead this comprehensive assessment of FDA’s process for reviewing medical device submissions.  The final report makes it clear that the goals of increasing consistency and predictability must be paramount in order to improve patient care and grow this important ecosystem.


“We agree with the report that FDA needs to develop criteria and establish mechanisms to improve consistency in decision making throughout the entire review process.  In addition, the full potential of enhanced processes can only be realized with adequate and consistent training across CDRH.


“MDMA looks forward to continue working with FDA and all stakeholders to improve the regulatory framework so that patients will have more timely access to safe and effective products.  We simply cannot fail at our common mission to help ensure that the United States remains the global leader in developing innovative medical technologies.”

To read the final report, click here.