What Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device (SaMD) Action Plan requires
This Action Plan outlines the U.S. Food and Drug Administration's (FDA) multi-pronged approach to advance its oversight of Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device (SaMD). Developed in response to stakeholder feedback on a 2019 discussion paper, the plan applies to medical device manufacturers utilizing AI/ML technologies. Its core objective is to establish a total product lifecycle-based regulatory oversight framework that allows SaMD to learn from real-world use and improve its performance while ensuring safety and effectiveness. A central component of this framework is the "Predetermined Change Control Plan" to be included in premarket submissions. This plan consists of two key elements: the "SaMD Pre-Specifications" (SPS), which describe the anticipated modifications, and the "Algorithm Change Protocol" (ACP), which details the methodology for implementing changes in a controlled manner that manages patient risks. The document details a five-part action plan: (1) issuing a Draft Guidance on the Predetermined Change Control Plan; (2) encouraging the harmonization of Good Machine Learning Practice (GMLP); (3) promoting a patient-centered approach that incorporates transparency to users through device labeling; (4) supporting regulatory science to develop methods for addressing algorithm bias and robustness; and (5) advancing real-world performance monitoring through pilot programs with stakeholders.
Pillar: Medical & Healthcare · Authority: U.S. FOOD & DRUG CENTER FOR DEVICES & RADIOLOGICAL HEALTH · Version: 1.0.0 · Last updated:
Primary source: https://www.fda.gov/media/145022/download
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- Introduction & Background: As part of this proposed framework, FDA described a 'Predetermined Change Control Plan' in premarket submissions. This plan would include the types of anticipated modifications-referred to as the 'SaMD Pre-Specifications'-and the associated methodology being used to implement those changes in a controlled manner that manages risks to patients -referred to as the 'Algorithm Change Protocol.'
- Action 1: Update the proposed framework for AI/ML-based SaMD, including through issuance of Draft Guidance on the Predetermined Change Control Plan.
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