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Mark Brager
February 9, 2016

AdvaMed Commends Senate HELP Action on FDA Device Accountability 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 mark up in the Senate HELP Committee of legislation to improve the efficiency of FDA’s medical technology review process:

“Today’s committee vote in favor of the FDA Device Accountability Act brings legislation that will help ensure more timely patient access to the latest medical innovations one step closer to enactment.

“This legislation includes common-sense reforms to eliminate redundant requirements at the agency and to help improve the agency’s medical technology review process. Specifically, the bill will require additional training and oversight so FDA reviews are done efficiently and expeditiously; allow device clinical trial sponsors to use a central Institutional Review Board to facilitate multi-center trials; and improve the CLIA-waiver process to accelerate the availability of point-of-care, rapid diagnostic information to physicians and patients.

“AdvaMed commends Sens. Richard Burr (R-N.C.) and Al Franken (D-Minn.) – the lead sponsors of the FDA Device Accountability Act – and Senate HELP Committee Chair Lamar Alexander (R-Tenn.) and Ranking Member Patty Murray (D-Wash.) for their leadership in moving this important legislation forward.”

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