CHINESE JOURNAL OF MEDICINAL GUIDE >
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
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.
Mingyu YOU
,
Jiazhen ZHANG
,
Shan JIANG
,
Tian TIAN
.
Classification-based Supervision of
the Allograft Bone and Case Analysis
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