Article preview from "The Gray Sheet"- August 15, 2011
Editors of two premier peer-reviewed medical journals are calling out FDA for its quick, dismissive response to the Institute of Medicine’s recommendation to replace the 510(k) program.
Article preview from "The Gray Sheet"- August 15, 2011
“The IOM report charts a path that is right for the future, and despite well-financed outside pressures, we urge FDA to initiate an action plan with congressional support to adopt these important recommendations,” Gregory Curfman, executive editor of the New England Journal of Medicine, and Rita Redberg, editor of the Archives of Internal Medicine, wrote in an Aug. 10 editorial published in NEJM.
FDA commissioned IOM in 2009 to assess how well the 510(k) program ensures device safety and effectiveness and promotes innovation, and to recommend needed changes.
But no one, including IOM, expected that the institute’s review committee would instead conclude that the program was basically unfixable and ought to be replaced.
“When the IOM Committee … began its work in early 2010, it did not grasp the weaknesses in the system,” committee members David Challoner and William Vodra wrote in a separate editorial also published in NEJM Aug. 10.
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