Expect more Class I recalls, inspections, analysts say
This article was originally published in The Silver Sheet
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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