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Corrections and removals reg's 10-day reporting deadline triggered by firms' internal meetings -- FDA.

This article was originally published in The Gray Sheet

Executive Summary

CORRECTIONS AND REMOVALS REG 10-DAY REPORTING DEADLINE TRIGGERED by a firm's internal decision on a recall, Casper Uldricks, Special Assistant to the Director of Compliance in FDA's Center for Devices and Radiological Health, explained at the Oct. 21 Association of Medical Diagnostics Manufacturers annual meeting in Rockville, Maryland. Noting that FDA's corrections and removals regulation is "very clear" that a firm must report within 10 working days when it initiates a Class I or Class II recall, the FDAer explained that "`Initiates' means that moment in time when a firm makes the first contact within or outside the firm that begins the corrective or removal action."

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