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MDMA Statement on the ICIJ Coverage of Medical Devices

Sunday, November 25, 2018  
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MDMA Statement on the ICIJ Coverage of Medical Devices

 

Washington, D.C. – Mark Leahey, President and CEO of the Medical Device Manufacturers Association (MDMA), issued the following statement today in response to the International Consortium of Investigative Journalists’ (ICIJ) coverage of medical devices and the regulatory pathways:


“FDA, innovators, patients, physicians and all stakeholders work tirelessly to strengthen the innovation ecosystem that develops the cures and therapies addressing our nation’s – and the world’s – most difficult health care challenges.  Simply put, the FDA’s regulatory framework is the gold standard in safety and efficacy.  

 

“The ICIJ’s coverage of this dynamic industry is cherry-picking a handful of adverse outcomes at the exclusion of the nearly 200,000 medical devices currently on the market improving patient care.  This only serves to frighten the millions of patients who benefit from medical technology innovation every day, while inaccurately portraying the rigorous regulatory pathways that are in place to ensure patient safety. 

 

“The doctors, engineers, manufacturers and all those who makeup the medical technology industry are committed to working closely with FDA and other stakeholders to ensure patients have access to technologies that improve the human condition, and that the United States remains the global leader in innovation.”  

 

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