Law360, New York (December 16, 2011, 6:59 PM ET) -- 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...
Sens. Float Bill To Improve Watch Over Medical Devices
To view the full article, take a free trial now.
