FDA Released Artificial Intelligence/Machine Learning 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• Further developing the proposed regulatory framework, including through issuance of draft guidance on a predetermined change control plan (for software’s learning over time);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.