“This action plan outlines the FDA’s next steps towards furthering oversight for AI/ML-based SaMD,” said Bakul Patel, director of the Digital Health Center of Excellence in the Center for Devices and Radiological Health (CDRH). “The plan outlines a holistic approach based on total product lifecycle oversight to further the enormous potential that these technologies have to improve patient care while delivering safe and effective software functionality that improves the quality of care that patients receive. To stay current and address patient safety and improve access to these promising technologies, we anticipate that this action plan will continue to evolve over time.”
The AI/ML-Based Software as a Medical Device Action Plan outlines five actions that the FDA plans to take:
- Develop the proposed regulatory framework, including through issuance of draft guidance on a predetermined change control plan (for software’s learning over time);
- Support the development of good machine learning practices;
- Foster a patient-centered approach, including device transparency to users;
- Develop methods to evaluate and improve machine learning algorithms; and
- Advance real-world performance monitoring pilots.
The AI/ML Action Plan is a response to stakeholder feedback received from the discussion paper, Proposed Regulatory Framework for Modifications to Artificial Intelligence/Machine Learning-Based Software as a Medical Device.