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Bone void filler guidance finalized

This article was originally published in The Gray Sheet

Executive Summary

"Bone void filler devices composed of alternate materials may be demonstrated to be substantially equivalent...to the resobable calcium salt bone void filler device identified in this guidance," FDA notes in its 1Class II special controls guidance on bone void fillers. However, FDA cautions that the guidance addresses only submission requirements and risk mitigation measures for resorbable calcium salt intended to fill bony gaps not intrinsic to the stability of the bony structure. Posted on the CDRH website May 28, the final guidance supersedes a Feb. 7, 2002 draft issued following a petition to reclassify Wright Medical Technologies' Osteoset into Class II (2"The Gray Sheet" Feb. 11, 2002, p. 11)...

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