生物骨科材料与临床研究2024，Vol.21Issue(3)：83-87,5.DOI:10.3969/j.issn.1672-5972.2024.03.016
可吸收运动医学植入物应用进展及同品种比对路径临床评价技术审评关键点
Application progress of absorbable sports medicine implants and the technical review key points of clinical evaluation by the same variety comparison path
摘要
Abstract
Absorbable sports medicine products can be gradually absorbed by the body after sports injury repair,avoiding the risk of foreign body reaction caused by the long-term existence of non-absorbable products,which has broad application prospects and attracts much market attention.In order to clarify the specific requirements of clinical evaluation which though comparison with predicate medical device and promote the successful registration of such products,this paper summarizes the absorbable sports medicine products and combines the emphasis in the clinical evaluation review process of some mature products(such as absorbable thread anchor,absorbable interface screw),refining the focus of clinical evaluation of the same species,to assist enterprises in design and development,guide regulatory agencies in technical review,and ensure the safety and efficacy of the declared product.关键词
可吸收/运动医学/临床评价Key words
Absorbable/Sports medicine/Clinical evaluation分类
医药卫生引用本文复制引用
程玮璐,张译丹,滕颖影,蒋研,刘英慧..可吸收运动医学植入物应用进展及同品种比对路径临床评价技术审评关键点[J].生物骨科材料与临床研究,2024,21(3):83-87,5.基金项目
国家重点研发计划(2018YFB1105600) （2018YFB1105600）
