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October 21, 2015

AdvaMed Commends Senators Donnelly & Gardner on Introduction of FDA Regulatory Efficiency Act

WASHINGTON, D.C. – JC Scott, senior executive vice president, government affairs, for the Advanced Medical Technology Association (AdvaMed), issued the following statement today following introduction in the Senate of legislation to improve the efficiency of FDA’s medical technology review process:

“AdvaMed commends Sens. Joe Donnelly (D-Ind.) and Cory Gardner (R-Colo.) for introducing the FDA Regulatory Efficiency Act, which will make improvements to 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. These changes would be limited to minor alterations to an existing product or manufacturing process currently covered by 30-day notices for PMAs and ‘special 510(k)s’ for 510(k) products.

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

“We look forward to working with members of Congress, FDA and other key stakeholders to move this important legislation forward.”

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