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Tracking rule reminder

This article was originally published in The Gray Sheet

Executive Summary

Joseph Levitt, the FDA device center's deputy director for regulations and policy, sends industry associations a reminder letter on FDA's tracking rule pointing out that the rule became final on Nov. 29 and will be effective Aug. 29. Levitt also informs the associations that the center is preparing a question and answer document for manufacturers that will "respond to many of the most prevalent concerns about device tracking." FDA decided to send the reminder letter because it has been slow in issuing a Federal Register notice that would formally announce the finalization of the rule and clarify some of its provisions ("The Gray Sheet" Nov. 2, p. 4).
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