Talk
IDE’s Risk Determination
Thu, Apr 24, 2025 · 9:40–10:40 AM PDT Hyatt Regency Newport Beach
About this session
This session will discuss Investigational Device Exemption’s (IDE) regulatory framework including risk determination and navigating the IDE regulatory process through real world examples. Additionally, we will discuss the STeP and Breakthrough Device Programs which provide patients and healthcare providers with timely access to devices that could provide more effective treatment or diagnosis or significantly improve the safety of currently available treatments or diagnostic by expediting their development, assessment, and review.
Speaker
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Retired Branch Chief, Premarket Programs Branch, Division of Industry and Consumer Education, CDRH · Food and Drug Administration
Speaker