FDA’s PCCP Draft Guidance Deep Dive
November 16 @ 11:30 am – 12:30 pm
The FDA released a draft of its first regulatory guidance centered on AI-enabled products in April, the “Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence/Machine Learning (AI/ML)-Enabled Device Software Functions.” Discuss with industry and FDA experts as they highlight the document’s significant features and challenges.
- Eric Henry, Senior Quality & Regulatory Compliance Advisor, FDA & Life Sciences Practice, King & Spalding
- Alex Cadotte, Senior Director, Digital Health and Imaging, MCRA
- Mira Jacobs, Acting Assistant Director, Digital Health Policy, Digital Health Center of Excellence, FDA
- Cassie Scherer, Senior Director US Regulatory and Global Digital Health Policy, Medtronic