Regulatory Issues Surrounding AI and Machine Learning Devices: U.S. FDA and European Perspectives

AI and Machine Learning (“AI/ML”) functionality in medical devices and software has been a focus area for regulators in recent years, as these tools represent a rapidly growing frontier in digital health. During this webinar, panelists will discuss the latest regulatory developments surrounding AI/ML, including such topics as:

• Borderline issues: AI/ML health applications that are not medical devices or otherwise unregulated
• AI/ML device approvals and clearances: Current status and trends in the U.S. and Europe
• Predetermined change controls plans, including FDA’s PCCP draft guidance and the guiding principles document issued jointly by the FDA, UK MHRA, and Health Canada
• Life cycle management considerations and premarket submissions recommendations for AL/ML-enabled device software functions
• President Biden’s Executive Order on AI
• EU AI Act, including proposal for financial penalties for regulatory breach and legislative proposal for non-contractual civil liability rules to AI