Tissue Debate Raises Fairness, Transparency Questions For Combo Products
This article was originally published in The Gray Sheet
Executive Summary
CDRH's decision to require 510(k) submissions for demineralized bone matrix (DBM) products is at odds with previous policy statements by the Center for Biologics Evaluation & Research, the American Association of Tissue Banks maintains in comments sent to the FDA center directors April 19
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Bone void fillers
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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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...
Wright Medical Group
Submission of a 510(k) application for the Arlington, Tennessee firm's Allomatrix products containing demineralized bone matrix is announced March 19. The submission responds to a recent "formal" notification from FDA, confirming a previous oral advisory that the products be regulated as medical devices, Wright says (1"The Gray Sheet" May 7, 2001, p. 17). No interruption in shipments is expected, according to Wright...