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Wednesday, September 25
Wed, Sep 25, 8:30 AM - 9:45 AM
Regulatory Experiences and Approaches of Using Historical Controls and Real-World Data in Product Development and Approval

Objective Study Design for Using Historical Controls and Real-World Data in Pre-Market Evaluation of Medical Devices: A Discussion with Examples (300945)

Heng Li, FDA/CDRH 
Nelson Lu, FDA/CDRH 
Vandana Mukhi, FDA/CDRH 
Ram Tiwari, FDA/CDRH 
*Yunling Xu, FDA/CDRH 
Lilly Q Yue, FDA/CDRH 

Keywords: historical control, real world data, pre-market, medical device, objective study design

Historical controls and real-world data have been playing an important role in the premarket evaluation of medical devices. For such studies, objective study design is a core component. In this presentation, good practice of objective study design for using historical controls and real-world data will be discussed and illustrated with examples.