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FDA - Food and Drug Administration (via Public) / FDA Collaborates with Health Canada and UK's MHRA to Foster Good Machine Learning Practice

FDA - Food and Drug Administration (via Public) / FDA Collaborates with Health Canada and UK's MHRA to Foster Good Machine Learning Practice
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Good Machine Learning Practice for Medical Device Development: Guiding Principles from the FDA

Good Machine Learning Practice for Medical Device Development: Guiding Principles from the FDA
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Genialis, BioLab Partner to Improve Precision Medicine Using Data Mining

Genialis, BioLab Partner to Improve Precision Medicine Using Data Mining
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FDA publishes Action Plan to regulate AI and ML based products

FDA publishes Action Plan to regulate AI and ML based products
The FDA has advanced an Action Plan focussed on possible means and methods of regulating AI/ML based products
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The Action Plan furthers and builds on concepts covered in a discussion paper released in April 2019
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On 12 January 2021, the US Food and Drug Administration (FDA) published a five part action plan which provides short-term actions to regulate products that incorporate artificial intelligence and/or machine learning (AI/ML). This Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device Action Plan was released by the Digital Health Centre of Excellence (DCE). The DCE launched on 22 September 2020 and exists within the FDA s Centre for Devices and Radiological Health. The DCE s aim is to further the FDA s overarching dedication to the advancement of digital health technology. ....

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Five highlights from FDA's new AI device regulation Action Plan | Hogan Lovells

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On January 12, the U.S. Food and Drug Administration’s Center for Devices and Radiological Health (CDRH) Digital Health Center of Excellence
released its new five-part “Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device (SaMD) Action Plan
,” which describes the agency’s efforts to regulate products that incorporate AI. It is a direct response to stakeholder feedback to the April 2019 discussion paper
, “Proposed Regulatory Framework for Modifications to Artificial Intelligence/Machine Learning-Based Software as a Medical Device.” Although the Action Plan is light on details for AI regulation, it pledges specific actions that show FDA is moving forward with its “Predetermined Change Control Plan” regulatory framework for machine learning devices. The docket ....

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