FDA's 5-step plan to regulate medical AI products

The FDA issued a five-pronged action plan to regulate medical products powered by artificial intelligence, the agency announced Jan. 12

Five measures the FDA plans to take:

  1. Further development of regulatory framework, including draft guidance on a change control plan for AI's learning over time

  2. Working toward the unified development of good machine learning practices to assess and improve AI algorithms

  3. Advocating for a patient-centric approach to AI design, including delivering device transparency to users

  4. Creating strategies to effectively evaluate and improve AI algorithms

  5. Supporting the expansion of real-world performance monitoring pilots

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