Software As a Medical Device: US FDA Regulatory and Legal Framework

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Tuesday, January 19, 2021
12:00 PM - 01:30 PM Eastern Standard Time
11:00 AM - 12:30 PM Central Standard Time
09:00 AM - 10:30 AM Pacific Standard Time

Join us as we discuss key FDA policies applicable to artificial intelligence (AI) and machine learning (ML) technologies when intended for healthcare applications. We will also cover FDA’s current regulatory scheme for AI/ML-based software and potential FDA exemptions that may apply. This session will further discuss recent FDA developments impacting AI/ML technologies.