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 Further development of regulatory framework, including draft guidance on a change control plan for AI's learning over time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

More articles on artificial intelligence:
MUSC creates AI tool to predict patients' risks for COVID-19 complications
3 recent studies exploring medical AI tools' efficacy
Children’s National Hospital, NIH launch COVID-19 diagnostics AI challenge

© Copyright ASC COMMUNICATIONS 2021. Interested in LINKING to or REPRINTING this content? View our policies by clicking here.