FDA Action Plan Puts Focus On AI-enabled Software As Medical Device

The agency plans to take a "multi-pronged approach" to advancing oversight of machine learning-enabled devices – with an eye toward ensuring patient safety, algorithm transparency and real-world results.

The U.S. Food and Drug Administration this week published its first action plan for how it intends to spur development and oversight of safe, patient-centric artificial intelligence and machine learning-based software as a medical device.

WHY IT MATTERS
The AI/ML-Based Software as a Medical Device Action Plan is a project of the Digital Health Center of Excellence at FDA's Center for Devices and Radiological Health, which launched this past September.

The action plan outlines five next steps FDA intends to take as AI/ML-based SaMD continues to evolve:

• Continuing to develop its own proposed regulatory framework for draft guidance on a predetermined change control plan for software learning
• Supporting "good machine learning practices" for evaluation of ML algorithms;
• Enabling a more transparent patient-centered approach
• Developing new methods to evaluate and improve machine learning algorithms; and
• Creating new pilots to enable real-world performance monitoring