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Senate committee proposes easier approval process for medical devices
The U.S. Senate Committee on Health, Education, Labor and Pensions favorably reported a measure today that would reduce regulatory hurdles for the approval of medical devices. The “FDA Device Accountability Act of 2015” (S. 1622), sponsored by Sens. Richard Burr, R-N.C.; and Al Franken, D-Minn., and co-sponsored by Mark Kirk, R-Ill., is intended to ensure the “least burdensome means” of evaluating medical devices, according to the bill’s authors. It requires that any FDA employee involved in the premarket submission process of medical devices receives training to make the approval of (Read more...)