April 24, 2024
@
12:05 pm
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1:30 pm
Harnessing the Power of Advances in Clinical Evidence
Pre Market Track
In the last few years, FDA has issued several guidance documents related to evidence generation for medical devices. This session is designed to explore these draft guidance documents, offering attendees a roadmap on how clinical evidence is being used to broaden diversity in studies and achieve streamlined and expedited evidence generation and review process.
Moderator
Shannon Hoste, Chief Scientific Officer, Pathway for Patient Health
Speaker
Felipe Aguel, Deputy Director, Office of Clinical Evidence and Analysis, Center for Devices and Radiological Health (CDRH), FDA
Daniel Canos, Director, Office of Clinical Evidence and Analysis, Center for Devices and Radiological Health (CDRH), FDA
Paul Coplan, Vice President and Global Head, Medical Device Epidemiology, Johnson & Johnson MedTech
Tom McLain, President, Renalytix
Simon Mason, President, National Evaluation System for health Technology Coordinating Center (NESTcc) part of MDIC