AI in Healthcare

The latest on artificial intelligence transforming medicine

News stories discovered and organized by an automated pipeline. Covering clinical deployments, research breakthroughs, regulation, and industry developments.

Filtered by: MDUFAClear filter
regulationCiteline News & Insights

FDA and Industry Reach MDUFA VI Framework Deal, Setting the Tone for Device Review Through 2031

FDA and medtech industry negotiators have reached an agreement in principle on the next Medical Device User Fee Amendments framework. The package will shape review resources, performance goals, and likely the operational environment for AI-enabled devices over the next cycle.

FDAMDUFAmedical devicesuser fees

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