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Contact:
Mark E. Brager
202-434-7244
mbrager@advamed.org
May 19, 2017

AdvaMed Supports Senate Quality System Certification Bill

WASHINGTON, D.C. – The Advanced Medical Technology Association (AdvaMed) issued the following statement from President and CEO Scott Whitaker following introduction in the U.S. Senate of legislation (S. 1183) to streamline FDA’s medical technology review process:

“AdvaMed commends Sens. Joe Donnelly (D-Ind.) and Cory Gardner (R-Colo.) for introducing legislation to improve the efficiency of FDA’s medical technology review process and help ensure more timely patient access to the latest medical innovations.

“This legislation would create a voluntary program under which medical technology companies could have their quality system certified by an FDA-authorized third party. This certification would allow companies to self-certify certain low-risk changes to currently marketed devices in lieu of a premarket submission. For 510(k)-cleared devices, these changes could not involve major technology changes or changes in the product’s intended use; for PMAs, the changes would be limited to manufacturing process changes currently covered by 30-day notices.

“This new program will help ensure that companies are held accountable for these minor changes while lessening the burden on FDA, allowing the agency to focus on higher-priority activities.

“A substantially similar proposal passed the House last year as part of the 21st Century Cures Act. We look forward to working with members of Congress, FDA and other key stakeholders on moving this important legislation.”