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In Brief: FDA device tracking and postmarket surveillance

This article was originally published in The Gray Sheet

Executive Summary

FDA device tracking and postmarket surveillance: Public meeting is scheduled for Jan. 15 at the Center for Devices and Radiological Health's Corporate building in Rockville, Maryland, to gather input on how the agency should implement changes to the tracking and PMS requirements mandated by the FDA Modernization Act. FDAers first announced plans for the meeting during a Dec. 3 videoconference ("The Gray Sheet" Dec. 8, p. 7). The agency also plans to issue a letter to industry in January reminding manufacturers that they must remain in compliance with the current requirements until FDA updates them...



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