Senate panel adds safety measures to FDA user fee act

April 25, 2012 by Brad Perriello

The U.S. Senate's Health, Education, Labor & Pensions Committee passes the "Food & Drug Administration Safety and Innovation Act," but fails to include provisions consumer advocates insist are necessary to protect patients from unsafe medical devices.

MassDevice.com news

A key U.S. Senate panel today approved a bill designed to tighten safety standards at the FDA's medical device arm, but the committee's markups to the measure failed to win support from consumer advocates.

The Senate's Health, Education, Labor and Pensions Committee voted to approve the "Food & Drug Administration Safety and Innovation Act," which would beef up the FDA's safety regulations, allowing the federal watchdog agency to conduct safety studies of devices after they've been approved and to grant conditional approvals contingent on further trials. The only "nay" in the voice vote was Sen. Bernie Sanders (I-Vt.).

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The bill, known as the "Medical Device Safety Act" when it was introduced late last year by Sens. Chuck Grassley (R-Iowa), Herb Kohl (D-Wis.) and Richard Blumenthal (D-Conn.), would also strengthen the FDA's 510(k) protocol, which allows device makers to show that their products are similar to already-cleared devices without requiring extensive clinical trials.

Hard on the heels of the panel's vote today, the advocacy arm of Consumer Reports, Consumers Union, issued a statement saying the bill still does not go far enough to keep patients safe from the flaws in the 510(k) system.

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