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Expect more Class I recalls, inspections, analysts say

This article was originally published in The Silver Sheet

Executive Summary

Device industry analysts say the FDA regulatory environment will become more challenging before eventually stabilizing, resulting in more Class I recalls and tougher manufacturing inspections. "Wholesale reform" of device regulation has been accelerated by the new FDA administration and CDRH Director Jeffrey Shuren, Morgan Stanley device analysts noted in a July 12 report. The analysts predict that device recalls will become more frequent and are more likely to be classified as Class I. "Class I recalls used to be fairly uncommon and pretty visible," Jeff Gibbs, an attorney with the Washington, D.C., law firm Hyman, Phelps &McNamara, said in a July 9 conference call hosted by Morgan Stanley. He questioned whether up-classifying recalls benefited public health, because "removing products from the market can be accomplished very effectively with a Class II recall." Further, the analysts noted that they expect to see more FDA-483 forms, listing possible violations, given to firms following an inspection

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