MONOGRAPH Published: 08 December 2014
MONO62014000211

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.

Author Information

Jiang, Tao
Institute for Regenerative Engineering, University of Connecticut Health Center, School of Medicine, Farmington, CT, US The Raymond and Beverly Sackler Center for Biomedical, Biological, Physical and Engineering Sciences, University of Connecticut Health Center, School of Medicine, Farmington, CT, US Department of Medicine, Division of Endocrinology, University of Connecticut Health Center, School of Medicine, Farmington, CT, US
Gadaleta, Sergio, J.
Becton Dickinson, Franklin Lakes, NJ, US
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Details
Developed by Committee: F04
Pages: 251–271
DOI: 10.1520/MONO62014000211
ISBN-EB: 978-0-8031-7061-2
ISBN-13: 978-0-8031-7060-5