FDA’s PCCP Draft Guidance Deep Dive

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.

Moderator

• Eric Henry, Senior Quality & Regulatory Compliance Advisor, FDA & Life Sciences Practice, King & Spalding

Speakers

• 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