Regulation
FDA seeks input on proposed regulatory approach to GenAI-based medtech
The FDA has opened a public comment period through October 2026 on its proposed regulatory framework for generative AI-based medical devices. The agency is seeking input from stakeholders on how to govern AI-enabled medtech while maintaining safety and efficacy standards.
The source
This brief is a MedIndexer summary of reporting by Medical Device Network. To read the full story, head to the source.
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