Medtechs need strategy to prevent bias in AI-machine learning-based devices: FDA
Healthcare
Source: healthcaredive.com
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FDA Announces Action Plan for Oversight of AI/ML in Medical Devices | Perkins Coie
To embed, copy and paste the code into your website or blog: 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 functionali...
Perkins Coie Patient Engagement Advisory Committee Artificial Intelligence Medical Devices Aimds Working Group International Medical Device Regulators Forum International Organization For Standardization Joint Technical Committee Drug Administration
Source: jdsupra.com
FDA Issues Artificial Intelligence/Machine Learning Action Plan | McDermott Will & Emery
To embed, copy and paste the code into your website or blog: 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take to further its oversight of AI/ML-based SaMD: Further develop the proposed regulatory framework, including through draft guidance on a predetermined change control plan for “learning” ML algo...
United Kingdom Electronics Engineers Institute Of Electrical Artificial Intelligence Medical Device Working Group International Organization For Standardization Joint Technical Committee Drug Administration
Source: jdsupra.com