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An article published in today's New England Journal of Medicine finds fault in FDA's regulatory system for medical devices, using the recall of Medtronic's ICD lead in 2007 as part of the basis for the criticism.

March 6, 2008

1 Min Read
Regulatory Process Criticized in Journal

Transforming FDA LogoAn article published in today's New England Journal of Medicine finds fault in FDA's regulatory system for medical devices, using the recall of Medtronic's ICD lead in 2007 as part of the basis for the criticism. According to author William Maisel, MD, the combination of the number of patients affected, money at stake in the market, and dialogue between doctors and patients about the product's performance "highlight the shortcomings of the regulatory system...and underscore the urgent need for legislation that will ensure adequate protection for the patients receiving them." Part of the problem, he writes, is that the Sprint Fidelis lead was approved based on bench testing, not human clinical data. He also says Medtronic failed to notify the public about the potential product defects and continued to sell the ICDs. From Maisel's perspective, patients have a right to be told about the possible risks of a device that will be implanted to ensure that they can make an informed decision. FDA has the duty to protect the public's health and is "failing to fulfill that mission," he says.

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