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Bone void fillers

This article was originally published in The Gray Sheet

Executive Summary

FDA special controls guidance for Class II resorbable calcium salt BVFs should not be applied to demineralized bone matrix (DBM) products, as has been suggested by the agency, Stryker Howedica Osteonics and the Orthopedic Surgical Manufacturers Association recommend in May comments. In a March 12 announcement, FDA indicated that DBMs would be regulated as devices (1"The Gray Sheet" April 29, 2002, p. 5). A separate guidance for DBMs should be issued, according to Stryker and OSMA...

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