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News and Press: Policy News

FDA Device Accountability Act

Thursday, July 16, 2015   (0 Comments)
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The “FDA Device Accountability Act” was introduced recently in the U.S. Senate. 

The bipartisan legislation means to re-introduce and strengthen the “Least Burdensome” provisions of the current law (FDA Modernization Act of 1997 (FDAMA)) to require faster, less burdensome product clearances and approvals. Specifically, it will require the agency to take steps so that medical technology reviews are done in the most efficient and expeditious manner possible; allow device clinical trial sponsors to use a central Institutional Review Board to facilitate the conduct of multi-center trials; and improve the CLIA-waiver process to accelerate the availability of point-of-care, rapid diagnostic information to physicians and patients.

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