GENERAL
2 min readFDA's New AI Tool Faces Technical Challenges Amid Agency Changes
TrueGov Editorial Team•8 months ago•2 min read
FDA Commissioner Makary pushes AI implementation despite reported limitations
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The Food and Drug Administration's new artificial intelligence tool designed to expedite medical device reviews is experiencing significant technical difficulties during beta testing, according to sources familiar with the project. The system, known internally as CDRH-GPT, reportedly struggles with basic functions including document uploads and connectivity to FDA internal systems, raising questions about its readiness for full implementation.