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Contact:
Mark E. Brager
202-434-7244
mbrager@advamed.org
November 28, 2018

AdvaMed Statement on FDA 510(k) Predicate Modernization Initiative

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

“Medical technology innovation is a dynamic and ever-evolving process designed to meet the changing and growing health care challenges patients face worldwide. Regulatory systems need to evolve as well to keep pace with this innovation while ensuring robust standards of safety and effectiveness. 

“We commend FDA’s commitment to fostering continued innovation for devices that go through the 510(k) process and look forward to working with the agency and other stakeholders on this next stage of evolution of the device review program.  

“It is important, however, that FDA move forward carefully and thoughtfully to ensure the new policy does not arbitrarily or inadvertently prevent the use of older predicates where the clinical and scientific information remains valid.  At the end of the process, it is critical that patients continue to have timely access to life-saving devices and diagnostics.”