同种异体骨移植物的分类监管及案例分析
收稿日期: 2025-06-30
修回日期: 2025-07-24
录用日期: 2025-12-24
网络出版日期: 2025-12-24
基金资助
上海市科学技术委员会基金（24692122800）
Classification-based Supervision of the Allograft Bone and Case Analysis
Received date: 2025-06-30
Revised date: 2025-07-24
Accepted date: 2025-12-24
Online published: 2025-12-24
同种异体骨移植作为骨修复领域的重要治疗手段，其供体来源的特殊性以及产品的安全有效性评价是监管机构关注的重点。本研究基于美国食品药品管理局（Food and Drug Administration，FDA）公开数据库资源，系统梳理并分析美国FDA对同种异体骨移植物实施的分类监管策略，通过全面检索相关监管信息，筛选典型监管案例，深入探究同种异体骨移植物相关公共卫生不良事件及其应对措施。该研究重点剖析FDA针对不同风险程度的同种异体骨移植物所采取的差异化监管策略，旨在探索并阐述国际监管领域对该类产品中的核心监管理念与监管思路。
尤茗语
,
张家振
,
江珊
,
田甜
.
同种异体骨移植物的分类监管及案例分析
Allograft bone， as a crucial therapeutic approach in bone repair， has drawn regulatory attention due to the specific considerations associated with donor sources and the evaluation of product safety and efficacy. This study systematically reviews and analyzes the US FDA's （Food and Drug Administration） classification-based regulatory strategies for allograft bone， utilizing the public database of the FDA. Through comprehensive retrieval of regulatory information and screening of representative regulatory cases， it delves into allograft bone associated public health adverse events and corresponding mitigation measures. The research focuses on dissecting the FDA's tiered regulatory approaches tailored to allograft bone with varying risk levels， aiming to elucidate the core regulatory principles and regulatory rationale for such products in the international regulatory landscape.
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