Artificial intelligence (AI) and Machine Learning (ML) present unique challenges for the FDA's regulatory framework. Pamela Forrest and Scott Danzis, Co-Chairs of Covington & Burling’s Medical Device Industry Group, will discuss the FDA's evolving approach to regulating AI-enabled devices. 

Topics will include:

• The 2021 AI/ML Action Plan
• Predetermined Change Control Plans
• The FDA’s upcoming November 2024 Advisory Committee Meeting on considerations for generative AI-enabled devices and therapies.

Join us on December 11th for an educational overview, followed by a Q&A session, and an opportunity to share experiences and insights in smaller roundtable discussions. Fill out the form below if you are interested in attending.