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Catch up on  this Webinar:

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  • Predetermined change controls plans, including FDA’s PCCP draft guidance and the guiding principles document issued jointly by the FDA, UK MHRA, and Health Canada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

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