FDA Seeks Patient, Provider Input As It Drafts Device AI Guide

By Luke Zarzecki / April 11, 2024 at 11:26 AM
FDA hopes to get input from patients and providers as it creates new draft guidance for artificial intelligence (AI) lifecycle management and content marketing submissions for AI-enabled devices, an agency official said Wednesday (April 10). The call comes as FDA works to strengthen its purview of AI. “I'm also hopeful that we'll hear feedback from patients and providers who can best tell us what kinds of information they'd like to know about AI-enabled devices in their performance, including their continued...

Not a subscriber? Sign up for 30 days free access to exclusive, detailed reporting on drug pricing reforms, Medicaid policy, FDA news and much more.