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FDA’s New AI/ML Device Regulation Action Plan

Posted By:  CITI Program Staff January 20, 2021

On 12 January 2021, the FDA announced a five-part action plan creating a framework which would enable FDA to further their oversight as well as provide a reasonable assurance of safety and effectiveness of artificial intelligence and machine learning-based software as a medical device (SaMD). This multi-faceted plan includes:

  1. Tailored Regulatory Framework for AI/ML-based SaMD
  2. Good Machine Learning Practice (GMLP)
  3. Patient-Centered Approach Incorporating Transparency to Users
  4. Regulatory Science Methods Related to Algorithm Bias & Robustness
  5. Real-World Performance (RWP)

FDA’s Artificial Intelligence/Machine Learning-Based Software as a Medical Device Action Plan


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