AI-Enabled Medical Devices: New FDA Draft Guidance and Cybersecurity Insights
The Food and Drug Administration (FDA) has issued draft guidance to establish a comprehensive regulatory framework for artificial intelligence and machine learning (AI/ML) in medical devices. As AI becomes embedded in connected health technologies, the cybersecurity risks associated with such devices are growing exponentially.
This webinar explores how the FDA's lifecycle-based approach to AI regulation intersects with cybersecurity for connected medical devices. Principals Barry Mathis and John Cross provided an overview of the FDA's draft guidance on AI/ML-enabled medical devices and…
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