Human bone allografts
This article was originally published in The Gray Sheet
Executive Summary
Public meeting scheduled for Aug. 2 at the NIH campus in Bethesda, Maryland, is being organized by FDA's devices and biologics centers to provide a public forum for gathering scientific data, information and views from interested persons about human bone allografts in relation to FDA's proposed tissue rules (1"The Gray Sheet" May 25, 1998, p. 13). Entitled "Human Bone Allograft: Manipulation and Homologous Use in Spine and Other Orthopedic Reconstruction and Repair," the meeting is intended to "provide stakeholders with the opportunity to present additional information to the agency," FDA says. The agency "is requesting specific information concerning the characteristics of various bone products as they relate to the agency's proposed definitions for minimal manipulation and homologous use"