Biomaterials and regulatory science

Xu Song ¹Zhonglan Tang ¹Wenbo Liu ²Kuan Chen ²Jie Liang ³Bo Yuan ⁴Hai Lin ⁴Xiangdong Zhu ⁴Yujiang Fan ⁴Xinli Shi ²Peng Zhao ²Lei Yang ⁵Kai Zhang ¹Antonios G.Mikos ⁶Xingdong Zhang¹

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作者信息

1. Institute of Regulatory Science for Medical Devices,Sichuan University,Chengdu 610064,China;National Engineering Research Center for Biomaterials,Sichuan University,Chengdu 610064,China;School of Biomedical Engineering,Sichuan University,Chengdu 610064,China
2. Center for Medical Device Evaluation,National Medical Products Administration,Beijing 100081,China
3. Institute of Regulatory Science for Medical Devices,Sichuan University,Chengdu 610064,China;National Engineering Research Center for Biomaterials,Sichuan University,Chengdu 610064,China;School of Biomedical Engineering,Sichuan University,Chengdu 610064,China;Sichuan Testing Center for Biomaterials and Medical Devices,Chengdu 610064,China
4. National Engineering Research Center for Biomaterials,Sichuan University,Chengdu 610064,China;School of Biomedical Engineering,Sichuan University,Chengdu 610064,China
5. Center for Health Sciences and Engineering,School of Health Sciences and Biomedical Engineering,Hebei University of Technology,Tianjin 300130,China
6. Departments of Bioengineering,Chemical and Biomolecular Engineering,Rice University,Houston,TX 77251,USA
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Abstract

The fast development of both biomaterials and regulatory science calls for a convergence,which is ad-dressed in this article via their link through medical products of biomaterials and related safety and efficacy evaluation.The updated definition of biomaterials,and concepts of biomaterials-related medi-cal products and so-called medical-grade and implantable materials are firstly introduced.Then a brief overview of the concept and history of regulatory science and its assessment of safety and efficacy of medical products,as well as the currently ongoing biomaterials-related regulatory science programs are presented.Finally,the opportunities provided by regulatory science for biomaterials as well as challenges on how to develop a biomaterials-based regulatory science system are discussed.As the first article in the field to elucidate the relationship between biomaterials and regulatory science,key take-home messages include(1)biomaterials alone are not medical products;(2)regulatory authorities approve/clear final medical products,not biomaterials;(3)there is no definition/regulation on the so-called medical-grade or implantable materials;and(4)safety and efficacy refer to final medical products,not biomaterials alone.

Key words

Biomaterials/Medical products/Regulatory science/Safety/Efficacy

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基金项目

四川省科技计划(2021YFS0020)

国家自然科学基金(32001002)

出版年

2022

材料科学技术(英文版)

中国金属学会中国材料研究学会中国科学院金属研究所

材料科学技术(英文版)

CSTPCDCSCDSCI

影响因子：0.657

ISSN：1005-0302

参考文献量59

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