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Contact:
Wanda Moebius
202-434-7240
wmoebius@advamed.org
June 18, 2015

AdvaMed Commends Senators Burr & Franken on Introduction of FDA Device Accountability Act

WASHINGTON, D.C. – Stephen J. Ubl, president and CEO of 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. Richard Burr (R-N.C.) and Al Franken (D-Minn.) for introducing the FDA Device Accountability 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 will require the agency to take steps so that medical technology reviews are done in the most efficient and expeditious manner possible; allow device clinical trial sponsors to use a central Institutional Review Board to facilitate the conduct of multi-center trials; and improve the CLIA-waiver process to accelerate the availability of point-of-care, rapid diagnostic information to physicians and patients.

“Taken together, these reforms will greatly improve the efficiency of FDA’s medical technology review process and eliminate redundant regulatory obstacles that impact the timeliness of American patients’ access to life-saving and life-enhancing innovations.

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

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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 www.advamed.org.