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Chapter 11 | Bone Graft Substitutes: A Regulatory Perspective
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Various synthetic bone graft substitutes, demineralized bone matrix (DBM), bone morphogenetic proteins (BMPs), allogeneic bone cells, and mesenchymal stem cells (MSCs) currently are legally marketed bone graft substitutes; however, each of these products has a distinct regulatory classification and, as such, requires a different regulatory path for approval before marketing. This chapter provides the readers with a rudimentary review of the classification of medical devices, the mechanisms by which a manufacturer may commercialize a medical device, and the current regulatory status of various bone graft substitutes available on the U.S. market.
bone graft substitutes, medical device, premarket notification, premarket approval, humanitarian device exemption
Jiang, Tao The Raymond and Beverly Sackler Center for Biomedical, Biological, Physical and Engineering Sciences, University of Connecticut Health Center, School of Medicine, Farmington, CTDepartment of Medicine, Division of Endocrinology, University of Connecticut Health Center, School of Medicine, Farmington, CT
Institute for Regenerative Engineering, University of Connecticut Health Center, School of Medicine, Farmington, CT
Gadaleta, Sergio J.
Becton Dickinson, Franklin Lakes, NJ