FDA's AI Tool for Medical Devices Stumbles with Basic Tasks

Jun 03, 2025
NBC News
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Summary

The FDA's new AI tool for reviewing medical devices, CDRH-GPT, is struggling with basic tasks like uploading documents and accessing recent studies, raising concerns about rushing AI adoption before it's ready to handle complex regulatory work accurately and safely.

Key Points

  • The FDA's new AI tool for reviewing medical devices is struggling with simple tasks like uploading documents and accessing recent studies.
  • The tool is buggy, not connected to the FDA's internal systems or the internet, and providing incorrect or incomplete summaries during testing.
  • There are concerns about rushing the AI tool's rollout before it's ready, potential conflicts of interest, and the tool eventually replacing human reviewers.

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