FDA extends feedback period on generative AI medical device rules and tests language models on radiology reports
The FDA has reportedly extended the feedback period for its review of rules on generative AI devices. It is also testing language models to evaluate AI radiology reports as the number of clearances grows.
Who is affected and how
- medtech company
- The regulatory framework for generative AI devices is still taking shape, so companies should use the opportunity to comment.
- health policy
- The FDA's experiments point to future methods of evaluating AI.
Sources
- FDA Extends Feedback Window, GenAI Medical Device Rules Under Rev | Bespoke Mentisbespokementis.com · Sep 21, 2026
- FDA Tests LLMs to Evaluate AI Radiology Reports as Clearances Mount | SMEDTEC Insights | SMEDTECsmedtec.co.uk · Sep 21, 2026
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