What Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device (SaMD) Action Plan requires
This Action Plan from the U.S. Food & Drug Administration (FDA) outlines a five-part strategy to regulate 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 aims to ensure that AI/ML-based SaMD is safe and effective while supporting innovation. The core of the proposed framework is a "Predetermined Change Control Plan" submitted by manufacturers, which includes the "SaMD Pre-Specifications" (SPS) detailing anticipated modifications and an "Algorithm Change Protocol" (ACP) explaining how changes will be implemented and validated. The plan applies to medical device manufacturers utilizing AI/ML technologies in SaMD. The five key actions are: 1) updating the regulatory framework, including issuing draft guidance on the Predetermined Change Control Plan; 2) encouraging the harmonization of Good Machine Learning Practices (GMLP); 3) promoting a patient-centered approach that incorporates transparency for users; 4) supporting regulatory science to address algorithm bias and robustness; and 5) advancing Real-World Performance (RWP) monitoring through pilot programs. This approach is intended to provide a total product lifecycle-based regulatory oversight, enabling the FDA to monitor software from premarket development through postmarket performance.
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: 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- Action Plan 1: The Agency intends to issue a draft guidance for public comment in this area. This draft guidance will include a proposal of what should be included in an SPS and ACP to support the safety and effectiveness of AI/ML SaMD algorithms.
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