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:
- Further development of regulatory framework, including draft guidance on a change control plan for AI's learning over time
- Working toward the unified development of good machine learning practices to assess and improve AI algorithms
- Advocating for a patient-centric approach to AI design, including delivering device transparency to users
- Creating strategies to effectively evaluate and improve AI algorithms
- Supporting the expansion of real-world performance monitoring pilots
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