Grassley Demands Details On FDA 510(k) Update

Law360, New York (February 18, 2010, 12:21 PM EST) -- Sen. Chuck Grassley, R-Iowa, is pressing the U.S. Food and Drug Administration for a status report on its efforts to update guidelines for medical device makers seeking approval to market and use modified devices through the agency's 510(k) clearance system.

More than four months have elapsed since the FDA admitted its current policy on when device modifications require new 510(k) submissions was not sufficiently clear and announced it would revise the guidelines, but the promised updates have yet to be released, Grassley wrote in a Feb....
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