FDA Released Artificial Intelligence/Machine Learning Action Plan

On 12 January 2021 the FDA released the agency’s first artificial intelligence/machine learning (AI/ML)-based software as a medical device (SaMD) action plan.

This AI/ML-Based Software as a Medical Device action plan describes a multi-pronged approach to advance the Agency’s oversight of AI/ML-based medical software. It outlines five actions that the FDA intends to take, including:

  • Further developing the proposed regulatory framework, including through issuance of draft guidance on a predetermined change control plan (for software’s learning over time);
  • Supporting the development of good machine learning practices to evaluate and improve machine learning algorithms;
  • Fostering a patient-centered approach, including device transparency to users;
  • Developing methods to evaluate and improve machine learning algorithms; and
  • Advancing real-world performance monitoring pilots.
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