Real World Evidence Conference

Session Chair(s)

This session will provide an update on the use of RWE for regulatory decisions for medical devices. Current plans and activities within the FDA’s Center for Devices and Radiological Health (CDRH) involving RWE will be presented by a CDRH speaker, including the parallel review program by CDRH for regulatory approval and Centers for Medicaid and Medicare Services (CMS) for coverage decisions. The session will assess methodological challenges with using RWE for regulatory decisions and work that the National Evaluation System for Health Technology (NEST) is doing to improve the methodology. The session will also address innovative developments of RWE within medical device companies and explore whether these can be used for regulatory decisions.

Learning Objective : At the conclusion of this session, participants should be able to:

• Discuss informed assessments of how RWE may be used for regulatory decisions
• Design and evaluate RWE strategies for medical devices for regulatory decisions
• Understand the trends and opportunities in research using RWE to evaluate medical devices

Speaker(s)