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The FDA and the Future of AI Oversight | Manatt, Phelps & Phillips, LLP

The FDA and the Future of AI Oversight | Manatt, Phelps & Phillips, LLP
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Medtechs need strategy to prevent bias in AI-machine learning-based devices: FDA

Healthcare ....

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Looking Beyond the Pandemic – AI and Digital Health Kick into Warp Speed | Butler Snow LLP

Looking Beyond the Pandemic – AI and Digital Health Kick into Warp Speed | Butler Snow LLP
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FDA Announces Action Plan for Oversight of AI/ML in Medical Devices | Perkins Coie

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On January 12, 2021, the U.S. Food and Drug Administration (FDA) released the Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device (SaMD) Action Plan (Action Plan). The Action Plan expresses that the “FDA’s vision is that, with appropriately tailored total product lifecycle-based regulatory oversight, AI/ML-based Software as a Medical Device (SaMD) will deliver safe and effective software functionality that improves the quality of care that patients receive.”
The FDA currently regulates and has approved “locked” SaMD utilizing AI/ML, but has struggled to determine the appropriate regulatory approach for “adapting” AI/ML SaMD that learns and evolves using real world inputs over time. The Action Plan is the FDA’s step forward to address this challenge. ....

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FDA Issues Artificial Intelligence/Machine Learning Action Plan | McDermott Will & Emery

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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:
Further develop the proposed regulatory framework, including through draft guidance on a predetermined change control plan for “learning” ML algorithms
FDA intends to publish the draft guidance on the predetermined change control plan in 2021 in order to clarify expectations for SaMD Pre-Specifications (SPS), which explain what “aspects the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 eff ....

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