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

Wednesday, April 18, 2018  
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MDMA Statement on FDA’s “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 “Medical Device Safety Action Plan” that was released by Commissioner Scott Gottlieb:


“MDMA applauds Commissioner Gottlieb and the FDA leadership for their ongoing commitment to protect patients while ensuring the United States’ regulatory system remain the world’s gold standard.  This plan will build upon improvements to the regulatory pathways that were enshrined in last year’s MDUFA reauthorization, and has the potential to expand efficiencies in the postmarket and premarket settings.  


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