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DEVICE FIRM REPORTS OF CORRECTIONS AND REMOVALS MUST INCLUDE

This article was originally published in The Gray Sheet

Executive Summary

DEVICE FIRM REPORTS OF CORRECTIONS AND REMOVALS MUST INCLUDE names, addresses and telephone numbers of all domestic and foreign recipients, purchasers and users under a proposed rule published in the March 23 Federal Register. The proposal, which applies to manufacturers, importers and distributors, also requires the reporting of the "dates and number of devices distributed to each such consignee," defined as "any person who received, purchased, or used the device." FDA is accepting comments on the proposed role until June 21.
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