On January 12, 2021, the US Food and Drug Administration (FDA) released its Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device (SaMD) Action Plan. The Action Plan outlines five actions that FDA intends to take to further its oversight of AI/ML-based SaMD:

1. Further develop the proposed regulatory framework, including through draft guidance on a predetermined change control plan for “learning” ML algorithms
   • FDA intends to publish the draft guidance on the predetermined change control plan in 2021 in order to clarify expectations for SaMD Pre-Specifications (SPS), which explain what “aspects the manufacturer changes through learning,” and Algorithm Change Protocol (ACP), which explains how the “algorithm will learn and change while remaining safe and effective.” The draft guidance will focus on what should be included in an SPS and ACP in order to ensure safety and effectiveness of the AI/ML SaMD algorithms. Other areas of focus include identification of modifications appropriate under the framework and the submission and review process.
2. Support development of good machine learning practices (GMLP) to evaluate and improve ML algorithms
   • GMLPs are critical in guiding product development and oversight of AI/ML products. FDA has developed relationships with several communities, including the Institute of Electrical and Electronics Engineers P2801 Artificial Intelligence Medical Device Working Group, the International Organization for Standardization/ Joint Technical Committee 1/ SubCommittee 42 (ISO/ IEC JTC 1/SC 42) – Artificial Intelligence, and the Association for the Advancement of Medical Instrumentation/British Standards Institution Initiative on AI in medical technology. FDA is focused on working with these communities to come to a consensus on GMLP requirements.
3. Foster a patient-centered approach, including transparency
   • FDA would like to increase patient education to ensure that users have important information about the benefits, risks and limitations of AI/ML products. To that end, FDA held a Patient Engagement Advisory meeting in October 2020, and the agency will use input gathered during the meeting to help identify types of information that it will recommend manufacturers include in AI/ML labeling to foster education and promote transparency.
4. Develop methods to evaluate and improve ML algorithms
   • To address potential racial, ethical or socio-economic bias that may be inadvertently introduced into AI/ML systems that are trained using data from historical datasets, FDA intends to collaborate with researchers to improve methodologies for the identification and elimination of bias, and to improve the algorithms’ robustness to adapt to varying clinical inputs and conditions.
5. Advance real world performance monitoring pilots
   • FDA states that gathering real world performance data on the use of the SaMD is an important risk-mitigation tool, as it may allow manufacturers to understand how their products are being used, how they can be improved, and what safety or usability concerns manufacturers need to address. To provide clarity and direction related to real world performance data, FDA supports the piloting of real world performance monitoring. FDA will develop a framework for gathering, validating and evaluating relevant real world performance parameters [...]
     
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