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FDA Unfazed By Brisk Pace Of In Vitro Diagnostics Class I Recalls

This article was originally published in The Silver Sheet

Executive Summary

A SURGE IN CLASS I IN VITRO DIAGNOSTICS RECALLS has stakeholders debating the significance of the upswing. FDA sees evidence that IVD manufacturers have honed their corrective and preventive action programs, while a clinical lab association suspects the recalls may point to problems in IVD clinical trial design. FDA Office of In Vitro Diagnostics Director Gutman’s calm response to the Class I increase reflects his non-confrontational approach to compliance overall, though one industry attorney cautions against companies letting down their guard. Recalling firms are determining root causes and implementing corrective actions

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