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:

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 Predetermined change controls plans, including FDA’s PCCP draft guidance and the guiding principles document issued jointly by the FDA, UK MHRA, and Health Canada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

Moderator:

1. Greg Levine, Partner, Ropes & Gray LLP

Speakers:

1. Sonja Fulmer, Deputy Director, FDA Digital Health Center of Excellence
2. Lincoln Tsang, Partner, Ropes & Gray LLP