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In Brief: Mass device reclassification

This article was originally published in The Gray Sheet

Executive Summary

Mass device reclassification: FDA is developing a concept paper for the mass reclassification of 40-50 preamendments Class III devices that will go through its reengineered regulation development process. The majority of the devices are those for which FDA has called for data under Sec. 515(i) of the device law. FDA plans on issuing a second mass reclassification for the remaining 515(i) devices for which data is due on Feb. 14 and Aug. 14, 1998. The agency also plans to propose reclassification of roughly 10 515(b) devices on an individual basis and a mass call for PMAs for 515(b) devices that have fallen into disuse...

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