The consideration and suggestion of real-world evidence and pre-marketing evaluation of medical devices_Chinese Journal of Evidence-Based Medicine

Authors：

LIU Lu , ZHONG Youjin , ZHANG Yujing , CUI Xinyue ,  XU Wei

Center for Medical Device Evaluation, National Medical Products Administration, Beijing, 100081, P.R.China;

Corresponding author：

XU Wei, Email: xuwei@cmde.org.cn

Keywords：

Real-world data; Real-world evidence; Medical device; Clinical evaluation

DOI：

10.7507/1672-2531.201905037

Video：

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Real-world data is been increasingly valued nowadays. This paper combined with related requirements of clinical evaluation of medical devices in China, studied the role of real-world evidence in pre-marketing clinical evaluation of medical devices in terms of technical evaluation, in aim of providing reference for the future application of China's real-world evidence in pre-marketing clinical evaluation.

Citation： LIU Lu, ZHONG Youjin, ZHANG Yujing, CUI Xinyue, XU Wei. The consideration and suggestion of real-world evidence and pre-marketing evaluation of medical devices. Chinese Journal of Evidence-Based Medicine, 2019, 19(8): 883-886. doi: 10.7507/1672-2531.201905037 Copy

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2.	孙鑫, 谭婧, 唐立, 等. 重新认识真实世界研究. 中国循证医学杂志, 2017, 17(2): 126-130.
3.	Han Y, Jing Q, Li Y, et al. Sustained clinical safety and efficacy of a biodegradable-polymer coated sirolimus-eluting stent in "real-world" practice: three-year outcomes of the CREATE (Multi-Center Registry of EXCEL Biodegradable Polymer Drug Eluting Stents) study. Catheter Cardiovasc Interv, 2012, 79(2): 211-216.
4.	国家食品药品监督总局. 关于发布接受医疗器械境外临床试验数据技术指导原则的通告(2018年第13号). Available at: http://samr.cfda.gov.cn/WS01/CL0087/222385.html.
5.	Premarket Approval (PMA) of heart ware ventricular assist system. Available at: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P100047.
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7.	许芸. 医疗器械超范围使用的审评思考. Available at: https://www.cmde.org.cn/CL0033/18724.html.
8.	孙鑫, 谭婧, 唐立, 等. 基于真实世界证据的上市后药品评价技术框架体系: 思考与建议. 中国循证医学杂志, 2018, 18(4): 277-283.
9.	Premarket Approval (PMA) of Medtronic micro trans catheter pacemaker system. Available at: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P150033.

1. Use of real-world evidence to support regulatory decision-making for medical devices: guidance for industry and food and drug administration staff. Available at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/use-real-world-evidence-support-regulatory-decision-making-medical-devices.
2. 孙鑫, 谭婧, 唐立, 等. 重新认识真实世界研究. 中国循证医学杂志, 2017, 17(2): 126-130.
3. Han Y, Jing Q, Li Y, et al. Sustained clinical safety and efficacy of a biodegradable-polymer coated sirolimus-eluting stent in "real-world" practice: three-year outcomes of the CREATE (Multi-Center Registry of EXCEL Biodegradable Polymer Drug Eluting Stents) study. Catheter Cardiovasc Interv, 2012, 79(2): 211-216.
4. 国家食品药品监督总局. 关于发布接受医疗器械境外临床试验数据技术指导原则的通告(2018年第13号). Available at: http://samr.cfda.gov.cn/WS01/CL0087/222385.html.
5. Premarket Approval (PMA) of heart ware ventricular assist system. Available at: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P100047.
6. Balancing premarket and post market data collection for devices subject to premarket approval guidance for industry and food and drug administration staff. Available at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/balancing-premarket-and-postmarket-data-collection-devices-subject-premarket-approval.
7. 许芸. 医疗器械超范围使用的审评思考. Available at: https://www.cmde.org.cn/CL0033/18724.html.
8. 孙鑫, 谭婧, 唐立, 等. 基于真实世界证据的上市后药品评价技术框架体系: 思考与建议. 中国循证医学杂志, 2018, 18(4): 277-283.
9. Premarket Approval (PMA) of Medtronic micro trans catheter pacemaker system. Available at: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P150033.

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The consideration and suggestion of real-world evidence and pre-marketing evaluation of medical devices

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