Sens. Float Bill To Improve Watch Over Medical Devices

Law360, New York (December 16, 2011, 6:59 PM EST) -- Sens. Chuck Grassley, R-Iowa, Richard Blumenthal, D-Conn., and Herb Kohl, D-Wis., introduced legislation Thursday that would heighten the U.S. Food and Drug Administration's post-market surveillance of medical devices to allow quicker detection of faulty products.

The Medical Device Patient Safety Act would hand the FDA the power to require companies to submit post-market data as a condition for winning approval for moderate-risk medical devices under the fast-track 510(k) process.

It would also require the FDA to assess its recalls to determine whether they were implemented effectively...
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