FDA’s PCCP Draft Guidance Deep Dive
November 14, 2023 @ 11:30 am
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12:30 pm
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 – View PDF Presentation
Cassie Scherer, Senior Director US Regulatory and Global Digital Health Policy, Medtronic
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.
