The proposal outlines a comprehensive strategy focused on overall device life-cycle monitoring to maximize the tremendous capacity these systems provide to transform patient safety by offering healthy and reliable software capabilities that improve the patients' care level.
FREMONT, CA: The U.S. Food and Drug Administration delivered the Agency's first Action Plan on Artificial Intelligence/ Machine Learning (AI/ML)-Based Software as a Medical Device (SaMD). This Action Plan outlines a multi-pronged solution to the Agency's regulation of AI/ML-based medical software.
This Action Plan details the FDA's next moves towards further regulation of the AI/ML-based SaMD. The proposal outlines a comprehensive strategy focused on overall device life-cycle monitoring to maximize the tremendous capacity these systems provide to transform patient safety by offering healthy and reliable software capabilities that improve the patients’ care level.
To keep up-to-date and discuss patient protection and increase access to these promising innovations, it is expected that this action plan will continue to develop over time. AI/ML-based program as a medical device action plan outlines the five steps the FDA plans to take, including:
• Further implementation of the planned regulatory system, including through the release of a draft guidance paper on a proposed change control plan (for software's learning over time);
• Enable the development of acceptable machine learning practices to test and Enhance machine learning algorithms;
• Encouraging a patient-centered approach, including customer openness of the device;
• Developing techniques for testing and developing machine learning algorithms;
• Advancing pilots to measure real-world performance.
The AI/ML Action Plan responds to input obtained from stakeholders in the April 2019 discussion paper, Draft Legislative Mechanism for Modifications to Artificial Intelligence/Machine Learning-Based Software as a Medical Device.
The FDA encourages ongoing input in this field and looks forward to partnering with stakeholders on these efforts. The organization will also continue to work closely through the FDA to create a structured strategy in areas of shared focus related to AI/ML. Begun in September 2020, the CDRH Digital Health Center of Excellence is dedicated to the strategic development of digital health technology research and evidence in the FDA's regulatory and supervisory role. The purpose of the Center is to enable partners to improve health care by promoting responsible and high-quality digital health innovation.