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Reclassification of preamendments devices

This article was originally published in The Gray Sheet

Executive Summary

Final rule issued March 31 withholds action on 10 of the 38 preamendments devices previously proposed for reclassification from Class III to Class II, including pacemaker lead adapters, annuloplasty rings and vascular graft prostheses less than 6 mm in diameter (1"The Gray Sheet" March 22, 1999, p. 10). The agency announced the postponement of action for six of the devices in June due to the lack of existing guidance to serve as special controls. Rule finalizes downclassification of remaining 28 devices, all of which are addressed by FDA guidance

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