Reading the Tea Leaves in FDA's AI-Enabled Device Guidelines
Cognizant's Dr. Scott Schell on Implications of AI for Regulatory Agenda
March 26, 2025
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About this episode
While recent draft guidance from the Food and Drug Administration on artificial intelligence-enabled medical devices is non-binding, the document signals that the agency is intensifying its regulatory scrutiny of these technologies, said Dr. Scott Schell of IT consulting firm Cognizant.