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Mark E. Brager
November 20, 2018

AdvaMed Statement on Updated 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 updated Medical Device Safety Action Plan:

“Patient safety is the number one priority of the medical technology industry, and we are always willing to look at new ways of ensuring patient safety -- whether on the regulatory end with FDA, or on the manufacturing and distribution side with new tools for monitoring and preventing adverse events.

“This is a collective effort, and one we can continually improve when we work together. FDA’s latest updates to its Medical Device Safety Action Plan are another positive step in this collective effort, and we’re ready to work with the agency and other stakeholders on ways to support the continued safety and effectiveness of medical devices.

“While we’re still reviewing the details of FDA’s updated Safety Plan, industry has long supported many of the programs highlighted, including development of the National Evaluation System for health Technology (NEST) to more efficiently generate better evidence on device performance and deployment of a unique device identification (UDI) system to ensure companies can effectively identify their products through their distribution and use while ensuring patient access to the most innovative, life-saving technologies.”