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Class I Recalls Break Record; FDA Begins Product-Specific Inquiries

This article was originally published in The Silver Sheet

Executive Summary

RECALLS OF MEDICAL DEVICES REACHED A RECORD LEVEL IN 2004, with 612 actions reported. A dramatic rise in Class I recalls has prompted FDA’s device center to look more closely at worrisome trends in certain product areas, including in vitro diagnostics. A new agency requirement for press releases on all Class I recalls should please consumers and members of Congress demanding greater openness from FDA, but a leading IVD industry spokeswoman questions the policy’s value to public health. Recent enforcement actions are a reminder that Class I recalls almost invariably lead to FDA scrutiny of a firm’s quality system





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