Biomaterials and regulatory science-猫眼课题宝

DOI：

10.1016/j.jmst.2022.04.018

发表时间：

2022-05

期刊：

Journal of Materials Science & Technology

影响因子：

通讯作者：

中科院分区：

其他

文献类型：

作者：

Xu Song;Zhonglan Tang;Wenbo Liu;Kuan-Hsin Chen;Jie Liang;Bo Yuan;Hai Lin;Xiangdong Zhu;Yujiang Fan;Xinli Shi;Peng Zhao;Lei Yang;Kai Zhang;A. Mikos;Xingdong Zhang

生物材料和监管科学的快速发展呼唤融合，本文通过生物材料的医疗产品和相关的安全性和有效性评估来阐述这一点。首先介绍了生物材料的最新定义，以及与生物材料相关的医疗产品和所谓医用级可植入材料的概念。然后简要概述了调控科学的概念和历史，它对医疗产品的安全性和有效性的评估，以及目前正在进行的与生物材料相关的调控科学计划。最后，讨论了调控科学为生物材料提供的机遇以及如何发展以生物材料为基础的调控科学体系的挑战。作为该领域第一篇阐明生物材料和监管科学之间关系的文章，关键的带回家的信息包括：(1)生物材料本身不是医疗产品；(2)监管机构批准/批准最终的医疗产品，而不是生物材料；(3)对所谓的医用级或可植入材料没有定义/监管；(4)安全性和有效性指的是最终医疗产品，而不仅仅是生物材料。

The fast development of both biomaterials and regulatory science calls for a convergence, which is addressed 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 medical 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.

Biomaterials and regulatory science

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