The FDA today released its first plan to regulate artificial intelligence/machine learning (AI/ML)-based Software as a Medical Device (SaMD).
The plan is a response to feedback received from the agency’s April 2019 discussion paper, “Proposed Regulatory Framework for Modifications to Artificial Intelligence/Machine Learning-Based Software as a Medical Device.”
It outlines five actions that the FDA intends to take, including:
- Further developing the proposed regulatory framework, including by issuing draft guidance on a predetermined change-control plan (for software’s learning over time).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.
- Advancing real-world performance monitoring pilots.
“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,” said Bakul Patel, director of the Digital Health Center of Excellence in the FDA’s Center for Devices and Radiological Health (CDRH), in a news release. “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 agency said it will continue to accept comments on the plan, which you can read here.