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Citizen Petition Proposed Rule Would Have Minimal Device Center Impact

This article was originally published in The Gray Sheet

Executive Summary

FDA's proposed rule winnowing actions that can be requested by citizen petitions is unlikely to have a significant impact on the Center for Devices and Radiological Health, staffers report. While the reg likely would cut down on the number of petitions filed, officials point out that the center has neither a backlog nor a persistent problem with "nuisance" petitions.

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