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Mark Brager
November 26, 2018

AdvaMed Statement on FDA 510(k) Modernization Plan

Washington, D.C. The Advanced Medical Technology Association (AdvaMed) issued the following statement from President and CEO Scott Whitaker on FDA’s 510(k) modernization plan: 

"The medical technology industry is committed to patient safety as its first priority, and we agree with FDA that the 510(k) process is a crucial part of the agency's 'gold standard for safety and effectiveness.' As FDA notes, the 510(k) process has served the American public well, facilitating patient and physician access to more than 190,000 devices since its inception with an extraordinary record of safety. 

"While we believe the 510(k) pathway has proven its effectiveness over the years, we have always maintained that any process can be improved. and we stand ready to work with FDA and all stakeholders toward the shared goal of enhancing the current review paradigm. We look forward to learning more about the agency's plans to implement an alternative 510(k) pathway and to encourage the use of more recent predicates. 

"FDA acknowledges that its concern with older predicates only applies to a minority of devices and that those devices have no demonstrated safety concerns. It is our hope that through the regulatory review, the agency will recognize that in some cases there are legitimate reasons for using older predicates, and that for some devices where the technology has changed little using those older predicates still makes sense. The proposed 10-year cut off criteria could prove arbitrary as older predicates can offer extensive data about their performance, which helps sponsors introduce newer, safer devices."