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Contact:
Mark E. Brager
(202) 434-7244
mbrager@advamed.org
April 17, 2018

AdvaMed Statement on FDA Medical Device Safety Action Plan

Washington, D.C. – The Advanced Medical Technology Association (AdvaMed) issued the following statement from President and CEO Scott Whitaker on FDA’s Medical Device Safety Action Plan:

“The medical technology industry is committed to patient safety, and we take great pride in the strong safety record of the devices and diagnostics we produce that are doing so much to save and improve the lives of millions of patients worldwide. We agree with Commissioner Gottlieb’s remarks that ‘safety and innovation should go hand in hand.’ While we are still reviewing the details of FDA’s Medical Device Safety Action Plan, we stand ready to work with the agency and other stakeholders on ways to support the continued safety and effectiveness of medical devices. Many of the provisions highlighted in the Safety Action Plan have enjoyed the strong support of industry for years, including development of a unique device identification (UDI) system, efforts to protect against cybersecurity threats, and the use of real-world evidence to improve the understanding of device performance pre- and post-market. The current regulatory framework has served the American public well as it has continued to evolve to keep pace with innovation, but we believe every process can be improved and welcome discussion of any proposal that would positively impact patient safety and access.”