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FDA's Approach to AI in Medical Products

FDA's Approach to AI in Medical Products
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FDA Charts Course for Regulating AI Used in Medical Products | McDermott Will & Emery

On March 15, 2024, four of the US Food and Drug Administration’s (FDA) medical products centers released a joint paper, titled “Artificial Intelligence & Medical Products: How CBER,...

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Artificial Intelligence Briefing: Sweeping EO "Establishes New Standards for AI Safety and Security" | Faegre Drinker Biddle & Reath LLP

President Biden has signed an executive order aimed at increasing AI security, protecting Americans’ privacy, and advancing equity and civil rights, among other goals. Meanwhile, the...

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Deciphering New US Laws Around Predetermined Change Control Plans

Deciphering New US Laws Around Predetermined Change Control Plans
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Medical Device Postmarket Change Controls FDA 510(k) Software Modification Guidance

Medical Device Postmarket Change Controls FDA 510(k) Software Modification Guidance
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FDA Finalizes Its Premarket Submissions Guidance for Medical Device Software Functions | King & Spalding

FDA Finalizes Its Premarket Submissions Guidance for Medical Device Software Functions | King & Spalding
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The Legal And Regulatory Landscape Evolving With AI In Life Sciences | MoFo Life Sciences

In the last ten years, more data and greater computing power have led to a boom in AI-related patent applications, with life and medical sciences emerging as a top application field. In...

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The Legal and Regulatory Landscape Evolving with AI in Life Sciences | TransPerfect Legal Solutions

In the last ten years, more data and greater computing power have led to a boom in AI-related patent applications, with life and medical sciences emerging as a top application field. In...

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FDA Issues Draft Guidance For Artificial Intelligence/Machine Learning (AI/ML)-Enabled Device Software Functions - Food and Drugs Law

A PCCP must be reviewed by FDA and established as part of a marketing authorization prior to a manufacturer's implementing any modifications under the PCCP.

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FDA Issues Draft Guidance for Artificial Intelligence/Machine Learning (AI/ML)-Enabled Device Software Functions | Goodwin

The US Food and Drug Administration (FDA or the Agency) recently issued its draft guidance titled “Marketing Submission Recommendations for a Predetermined Change Control Plan for...

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