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Public Citizen Opposes Medical Device Bills to Be Marked Up Before Senate Committee

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Public Citizen writes to the Senate Health, Education, Labor, and Pensions Committee to oppose two bills that are scheduled to be marked up March 9, 2016. The bills would advance dangerous provisions weakening the Food and Drug Administration’s (FDA’s) power to regulate medical devices. One measure would lower approval standards for products that combine devices with drugs or biological products, and the other would pressure the FDA to take shortcuts that would lower the quality of information available for FDA review of medical devices. Both bills should be rejected, and no Senate-passed measures should be combined with the 21st Century Cures legislation, which would put patient lives at risk and compromise public health.