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Mark Brager
February 26, 2014

AdvaMed Statement on FDA 510(k) Report to Congress

WASHINGTON, D.C. – Janet Trunzo, senior executive vice president, technology and regulatory affairs, for the Advanced Medical Technology Association (AdvaMed), issued the following statement in response to FDA’s report to Congress on requirements for submitting a new 510(k) for a modification to a currently marketed device:

“While we are still reviewing all the details of the report, AdvaMed commends FDA for listening to our views and for the agency’s willingness to incorporate many of our recommendations in the future 510(k) modifications guidance.

“Most importantly, FDA has decided to modify its existing guidance – issued in 1997 – rather than create an entirely new document. The 1997 guidance has served innovation and patients well for many years, and we agree with the agency that it should be revised and strengthened to address any areas that lack clarity or consistency.

“We also are pleased that FDA has indicated it will retain the use of flow charts in its future guidance. These are an important and useful decision-making tool in the 1997 guidance and help provide 510(k) submitters a clear indication of when a submission is required for a modification to their currently marketed device.

“Finally, we support the agency’s move to address certain types of changes – such as those involving software – in a separate guidance.

“We look forward to providing more detailed comments on FDA’s report to Congress and on the eventual draft guidance the agency will be developing.”

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AdvaMed member companies produce the medical devices, diagnostic products and health information systems that are transforming health care through earlier disease detection, less invasive procedures and more effective treatments. AdvaMed members range from the largest to the smallest medical technology innovators and companies. For more information, visit