April 24, 2024
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1:50 pm
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2:50 pm
FDA’s PCCP Draft Guidance Deep Dive
Digital Health Track
The FDA released a draft of its first regulatory guidance centered on AI-enabled products in April with the “Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence/Machine Learning (AI/ML)-Enabled Device Software Functions” draft guidance. Listen to 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, Vice President, Digital Health, AI & Radiology, MCRA
Jessica Paulsen, Digital Health Associate Director, Office of Product Evaluation and Quality, Center for Devices and Radiological Health (CDRH), FDA
Cassie Scherer, Senior Director US Regulatory and Global Digital Health Policy, Medtronic