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：

Export PDF Favorites Scan Get Citation

Abstract Full text Figures/Tables Video References Cited by

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

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.	孫鑫, 譚婧, 唐立, 等. 重新認識真實世界研究. 中國循證醫學雜志, 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.	國家食品藥品監督總局. 關于發布接受醫療器械境外臨床試驗數據技術指導原則的通告(2018年第13號). 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.	許蕓. 醫療器械超范圍使用的審評思考. Available at: https://www.cmde.org.cn/CL0033/18724.html.
8.	孫鑫, 譚婧, 唐立, 等. 基于真實世界證據的上市后藥品評價技術框架體系: 思考與建議. 中國循證醫學雜志, 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. 孫鑫, 譚婧, 唐立, 等. 重新認識真實世界研究. 中國循證醫學雜志, 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. 國家食品藥品監督總局. 關于發布接受醫療器械境外臨床試驗數據技術指導原則的通告(2018年第13號). 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. 許蕓. 醫療器械超范圍使用的審評思考. Available at: https://www.cmde.org.cn/CL0033/18724.html.
8. 孫鑫, 譚婧, 唐立, 等. 基于真實世界證據的上市后藥品評價技術框架體系: 思考與建議. 中國循證醫學雜志, 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.

Next Article
APACHEⅡ, NEWS, PESI and CCI for predicting mortality in patients with pulmonary embolism: a comparative study

Chinese Journal of Evidence-Based Medicine

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

Abstract Full text Figures/Tables Video References Cited by

Next Article

Format

Content