An Official Journal of Polish Society of Orthopaedics and Traumatology
ISSN:1897-2276
e-ISSN: 2449-9145
Jonathan Boyd
American Association of Tissue Banks, USA
Posters & Accepted Abstracts: J Arthroplasty
Processing and classification of most human cell and cellular based tissue products has remained the same for decades. The basic homologous function of transplanted osteocondrial allografts and total joint replacements utilizing allografts has fundamentally followed suite. However, guidance from the United States Food and Drug Administration may shift some of these approaches and the grafts which are available for implantation or transplantation. The purpose of this presentation is to review and evaluate changes in processing, distribution, classifications and possible shift in the United States tissue banking community to medical devices and biologics as a result of this guidance providing and developing different options in arthroplasty. The Learning Objectives and expected outcomes of this study is to Outline previous guidance and regulation, Summarize the current options and limitations in human cell and cellular based tissue products, to review potential changes in guidance and regulation and finally to summarize the impact and potential changes to arthroplastic allograft application
E-mail: BoydJ@aatb.org
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