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Mark Brager
June 8, 2016

AdvaMed Statement on House Medical Device Bills from Reps. Fitzpatrick & Slaughter

WASHINGTON, D.C. – JC Scott, senior vice president, government affairs for the Advanced Medical Technology Association (AdvaMed), issued the following statement on medical device legislation introduced today by Reps. Mike Fitzpatrick (R-Pa.) and Louise Slaughter (D-N.Y.):

“We appreciate Reps. Fitzpatrick and Slaughter’s interest in this issue and share their commitment to ensuring America patients have access to safe and effective medical devices.

“AdvaMed is still reviewing the text of the two bills introduced today. However, regarding the Medical Device Guardian Act, we encourage all stakeholders – physicians, hospitals and manufacturers – to submit reports as required under FDA’s medical device reporting regulations.

“Regarding the preemption legislation, we believe FDA scientists and engineers are best suited to making safety and effectiveness determinations of complex medical technologies, carefully balancing benefits and risks. It is important to note that FDA preemption has been reaffirmed at every court level, including the U.S. Supreme Court by an 8-1 decision in the 2008 Riegel case. In its opinion, the Supreme Court recognized the importance of ensuring that regulators, not courts, make decisions about the safety and efficacy of medical devices.”

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