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SPP expresses concerns about The Combination Products Innovation Act of 2015 (S.1767) and The Advancing Breakthrough Medical Devices for Patients Act of 2015 (S.1077)

In this letter, the Safe Patient Project at Consumers Union expresses concerns about The Combination Products Innovation Act of 2015 (S.1767) and The Advancing Breakthrough Medical Devices for Patients Act of 2015 (S.1077). S. 1767 would effectively lower approval standards for combination products by making it easier for a greater number to be classified and reviewed as devices. The Advancing Breakthrough Medical Devices for Patients Act of 2015 (S. 1077) would, in order to create expedited review for devices deemed “breakthroughs,” lower the already insufficient clinical standards for medical device approval. As patient safety consumer advocates who have worked extensively on medical device safety issues, we believe these bills would weaken approval standards and potentially put patients at risk for harm.

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