April 24, 2024
FDA’s PCCP Draft Guidance Deep Dive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Change Control Plan for Artificial Intelligence/Machine Learning (AI/ML)-Enabled Device Software Functions” draft guidance.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.
Alex Cadotte, Senior Director, Digital Health and Imaging, 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