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MDMA Statement on FDA’s Updates to the “Medical Device Safety Action Plan”

Monday, November 26, 2018  
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MDMA Statement on FDA’s Updates to the “Medical Device Safety Action Plan”


Washington, D.C. – Mark Leahey, President and CEO of the Medical Device Manufacturers Association (MDMA), issued the following statement today in response to FDA’s updates to their “Medical Device Safety Action Plan:”


“FDA is the gold standard when it comes to determining the safety and effectiveness of medical technologies. As MDMA reviews the updates to the FDA’s ‘Medical Device Safety Action Plan,’ we strongly encourage Congress to provide the additional $46 million requested in the President’s budget to expand the agency’s ability to assess medical device performance.  These additional resources would allow FDA to continue to improve what is already a tremendous track record of protecting patients and spurring innovation.


“Medical technology innovators remain steadfast as we work with FDA and all stakeholders to expedite patient and provider access to safe and effective cures and therapies, while making sure America’s patients are the first to benefit from American innovations.”