Lawmakers Urge FDA To Overhaul Medical Device Database

Law360, New York (August 15, 2012, 6:49 PM EDT) -- Lawmakers on Wednesday urged the U.S. Food and Drug Administration to overhaul its database covering medical devices that are approved due to their similarity to those already on the market, claiming it doesn’t adequately show if devices have been recalled because of safety issues.

U.S. Rep. Ed Markey, D-Mass., and Sen. Jeff Merkley, D-Ore., said the FDA should make changes to its so-called 510(k) database so that it clearly indicates devices that have been recalled for serious design flaws that could affect their safety or effectiveness,...
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