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A regulatory perspective on recombinant collagen-based medical devices
As a class of novel biomaterials manufactured by synthetic biology technologies, recombinant collagens are candidates for a variety of medical applications. In this article, a regulatory scientific perspective on recombinant collagens and their medical devices is presented with a focus on the defini...
Autores principales: | , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
KeAi Publishing
2021
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8897173/ https://www.ncbi.nlm.nih.gov/pubmed/35310384 http://dx.doi.org/10.1016/j.bioactmat.2021.10.031 |
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author | Liu, Wenbo Lin, Hai Zhao, Peng Xing, Lina Li, Jie Wang, Zehua Ju, Shan Shi, XinLi Liu, Yinghui Deng, Gang Gao, Guobiao Sun, Lei Zhang, Xindong |
author_facet | Liu, Wenbo Lin, Hai Zhao, Peng Xing, Lina Li, Jie Wang, Zehua Ju, Shan Shi, XinLi Liu, Yinghui Deng, Gang Gao, Guobiao Sun, Lei Zhang, Xindong |
author_sort | Liu, Wenbo |
collection | PubMed |
description | As a class of novel biomaterials manufactured by synthetic biology technologies, recombinant collagens are candidates for a variety of medical applications. In this article, a regulatory scientific perspective on recombinant collagens and their medical devices is presented with a focus on the definition, translation, classification and technical review. Recombinant collagens are categorized as recombinant human collagen, recombinant humanized collagen and recombinant collagen-like protein, as differentiated by specific compositions and structures. Based on their intended uses and associated risks, recombinant collagen-based medical devices are generally classified as Class Ⅱ or Ⅲ in China. The regulatory review of recombinant collagen-based medical devices aims to assess their safety and efficacy demonstrated by scientific evidences generated from preclinical and clinical evaluations. Taken together, opportunities as well as challenges for their future clinical translation of recombinant collagen-based medical devices abound, which highlights the essential role of regulatory science to provide new tools, standards, guidelines and methods to evaluate the safety and efficacy of medical products. |
format | Online Article Text |
id | pubmed-8897173 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2021 |
publisher | KeAi Publishing |
record_format | MEDLINE/PubMed |
spelling | pubmed-88971732022-03-17 A regulatory perspective on recombinant collagen-based medical devices Liu, Wenbo Lin, Hai Zhao, Peng Xing, Lina Li, Jie Wang, Zehua Ju, Shan Shi, XinLi Liu, Yinghui Deng, Gang Gao, Guobiao Sun, Lei Zhang, Xindong Bioact Mater Perspective As a class of novel biomaterials manufactured by synthetic biology technologies, recombinant collagens are candidates for a variety of medical applications. In this article, a regulatory scientific perspective on recombinant collagens and their medical devices is presented with a focus on the definition, translation, classification and technical review. Recombinant collagens are categorized as recombinant human collagen, recombinant humanized collagen and recombinant collagen-like protein, as differentiated by specific compositions and structures. Based on their intended uses and associated risks, recombinant collagen-based medical devices are generally classified as Class Ⅱ or Ⅲ in China. The regulatory review of recombinant collagen-based medical devices aims to assess their safety and efficacy demonstrated by scientific evidences generated from preclinical and clinical evaluations. Taken together, opportunities as well as challenges for their future clinical translation of recombinant collagen-based medical devices abound, which highlights the essential role of regulatory science to provide new tools, standards, guidelines and methods to evaluate the safety and efficacy of medical products. KeAi Publishing 2021-10-29 /pmc/articles/PMC8897173/ /pubmed/35310384 http://dx.doi.org/10.1016/j.bioactmat.2021.10.031 Text en © 2021 The Authors https://creativecommons.org/licenses/by-nc-nd/4.0/This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/). |
spellingShingle | Perspective Liu, Wenbo Lin, Hai Zhao, Peng Xing, Lina Li, Jie Wang, Zehua Ju, Shan Shi, XinLi Liu, Yinghui Deng, Gang Gao, Guobiao Sun, Lei Zhang, Xindong A regulatory perspective on recombinant collagen-based medical devices |
title | A regulatory perspective on recombinant collagen-based medical devices |
title_full | A regulatory perspective on recombinant collagen-based medical devices |
title_fullStr | A regulatory perspective on recombinant collagen-based medical devices |
title_full_unstemmed | A regulatory perspective on recombinant collagen-based medical devices |
title_short | A regulatory perspective on recombinant collagen-based medical devices |
title_sort | regulatory perspective on recombinant collagen-based medical devices |
topic | Perspective |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8897173/ https://www.ncbi.nlm.nih.gov/pubmed/35310384 http://dx.doi.org/10.1016/j.bioactmat.2021.10.031 |
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