摘要
目的:研究FDA医疗器械上市前评审过程中进行受益–风险评估时需要考虑的因素,为我国医疗器械产品的科学审评提供参考。方法:采用文献分析和比较研究的方法,研究美国食品药品管理局发布的《医疗器械上市前批准(PMA)和新分类界定受益–风险评估时应考虑的因素》。结果:通过将我国与美国医疗器械注册审评过程评价进行比较,结果显示,我国与FDA医疗器械注册审评基本原则相同,均是基于产品风险分类,通过有效的科学证据判定产品的安全性和有效性。结论:制定"受益–风险评估工作清单"有利于促进医疗器械的科学审评,提高上市前审评过程的可预测性、一致性和透明度。
Objective： Investigation of factors Food and Drug Administration （FDA） considers in making benefit–risk determinations involved in the FDA medical device premarket review process. This article provides a reference for developing medical device premarket review process in China. Methods： Translation and analysis of Factors to Consider When Making Beneft–risk Determinations in Medical Device Premarket Approval and De Novo Classifcation published by FDA. Results： Comparison of medical device premarket review process between CFDA and US FDA shows that the fundamental principal are similar in China FDA and US FDA. The medical device premarket approval is made based on the classfcation of the device. Efective scientifc evidences are used to justify the safety and efacy of the device. Conclusions： A unifed “Worksheet for Beneft–Risk Determinations” would enhance the prediction, consistency and transparency of the premarket review process. the predictability, consistency, and transparency of the premarket review process.
作者
石莉
李非
程茂波
卢红
商惠
梁文
迟戈
赵挺
陈福军
马艳彬
SHI Li;LI Fei;CHENG Mao-bo;LU Hong;SHANG Hui;LIANG Wen;CHI Ge;ZHAO Ting;CHEN Fu-jun;MA Yan-bin(Liaoning Food and Drug Administration Technical Evaluation Center,Liaoning Shenyang 110003;Center for Medical Device Evaluation.CFDA,Beijing 100081)
出处
《中国医疗器械信息》
2018年第19期1-4,32,共5页
China Medical Device Information
关键词
医疗器械
受益-风险
科学审评
安全有效
medical device
beneft–risk
scientifc evaluation
safe and efective
