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Volume 359:88-89 July 3, 2008 Number 1
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Medical-Device Safety and the FDA

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by Maisel, W. H.
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To the Editor: In his Perspective article, Maisel (March 6 issue)1 criticizes the response of the Food and Drug Administration (FDA) to adverse events preceding the recall of Medtronic's Sprint Fidelis implantable cardioverter–defibrillator (ICD) leads. The FDA agrees with Maisel's premise that physicians and patients should receive accurate and timely information about problems with marketed medical devices. In fact, we are increasing our efforts to issue early communications about potential problems with regulated medical products, and we have created a new Risk Communication Advisory Committee to help us do so. However, we are concerned about several statements in Maisel's article . . . [Full Text of this Article]



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