Online Program

Return to main conference page
Tuesday, September 24
Tue, Sep 24, 4:15 PM - 5:30 PM
Thurgood Marshall North
Real-World Evidence, Regulatory Decisions, and Product Safety and Effectiveness

Incorporating Real-World Data for Regulatory Decision-Making in Medical Device Evaluation (300951)

*Lilly Q Yue, FDA/CDRH 

Keywords: Real-world data, Real-world evidence, Regulatory decision-making

In medical product development, there has been an increased interest in utilizing real-world data (RWD) which have become abundant owing to advances in biomedical science, information technology and engineering. High-quality real-world data may be utilized to generate real-world evidence (RWE) for regulatory decision-making. This presentation will focus on practice and perspectives on the use of RWD and RWE in regulatory decision-making for medical devices, illustrated with examples from our pre-market reviews.