美国医疗器械附条件批准介绍及启示

doi:10.19803/j.1672-8629.20230078

摘要/Abstract

摘要： 目的为平衡医疗器械上市前证据支撑和上市后研究收集的相关工作,提高医疗器械上市前批准的科学决策提供参考。方法通过介绍美国食品药品监督管理局（FDA）医疗器械附条件批准指南内容和批准情况,并与我国相关政策进行比较分析,得出我国医疗器械全生命周期管理的相关建议。结果 FDA修订发布医疗器械附条件批准的相关指南,对上市后研究的要求可供我国监管参考。我国对治疗严重危及生命且尚无有效治疗手段疾病的医疗器械,应当充分考虑医疗器械上市后预期收集的数据与上市前已收集的数据之间的平衡性,提高对所附条件的跟踪评价能力。结论附条件批准的医疗器械产品特殊性在于可通过上市后预期收集的数据来平衡上市前所做的研究工作,前提是应对所附条件进行及时跟踪和评价,必要时及时采取相应的监管措施。建议我国医疗器械监管部门通过明确项目具体情形、规范附条件批准信息的撰写、加快上市后监管频率和建立医疗器械全生命周期监管信息化系统,提升审评科学决策的水平和能力。

关键词: 医疗器械, 附条件, 上市前审评, 全生命周期

Abstract: Objective To provide a reference for balancing the related work of pre-marketing evidence support and post-marketing research collection of medical devices, and to improve the scientific decision-making level of pre-marketing approval of medical devices. Methods By introducing the content and approval of the U.S. Food and Drug Administration (FDA) guidelines for conditional approval of medical devices were sorted out, and the relevant policies in China were compared. The relevant recommendations for the whole life cycle management of medical devices in China were obtained. Results FDA revised the relevant guideline of medical device conditional approval, which can be referenced by China's regulatory for the requirements of post-market study. In China, the balance between the expected data collected after the approval and before the market should be fully considered for medical devices that treat diseases that are seriously life-threatening and which do not have effective treatment methods. Conclusion The specificity of the conditional approved medical device product is that the pre-market research can be balanced by the data that is expected to be collected after approval, provided that the conditions attached to it are followed up and evaluated in a timely manner and, if necessary, appropriate regulatory measures are taken. It is recommended that China's medical device regulatory authorities improve the level and capability of reviewing scientific decision-making by clarifying the specific circumstances of the project, standardising the writing of conditional approval information, accelerating the frequency of post-market surveillance and establishing a medical device full life-cycle regulatory information system.

Key words: medical devices, conditional approval, pre-market evaluation, full life cycle

中图分类号:

R951

仉琪, 陈敏, 张世庆. 美国医疗器械附条件批准介绍及启示[J]. 中国药物警戒, 2023, 20(9): 1007-1010.

ZHANG Qi, CHEN Min, ZHANG Shiqing. Conditional approval of medical devices in the United States and enlightenment[J]. Chinese Journal of Pharmacovigilance, 2023, 20(9): 1007-1010.

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