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FDA Issues Draft Guidance for Artificial Intelligence/Machine Learning (AI/ML)-Enabled Device Software Functions | Goodwin

The US Food and Drug Administration (FDA or the Agency) recently issued its draft guidance titled “Marketing Submission Recommendations for a Predetermined Change Control Plan for.

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FDA Issues Draft Guidance Related to Marketing Submissions for AI/ML-Enabled DSFs, and Final Guidance Describing the FDA s Adoption of Section 524B Ensuring Cybersecurity of Devices | Wilson Sonsini Goodrich & Rosati

The U.S. Food and Drug Administration (FDA) is continuing its effort to provide industries with updated guidance for digital health technologies. On April 3, 2023, the FDA released.

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Artificial Intelligence Briefing: New York City Department of Consumer and Worker Protection Ready to Enforce Regulation of Automated Employment Decision Tools | Faegre Drinker Biddle & Reath LLP

Our latest briefing dives into new local laws about AI and how it affects both employment and insurance industries, the launch of NIST’s Trustworthy & Responsible Artificial.

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FDA Releases Guidance on Submissions for AI/ML-Enabled Devices | Foley Hoag LLP

On April 3, 2023, the Food and Drug Administration (FDA) published in the Federal Register an announcement of availability for the draft guidance, Marketing Submission Recommendations.

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The FDA Regulatory Landscape For AI In Medical Devices

This article reviews the existing FDA programs impacting artificial intelligence (AI) / machine learning (ML) technologies in medtech, as well as the.

United kingdomJake harperJacobj harperMichele buenafeMichelel buenafeAndrew grayAndrewj grayOffice of inspectorQuality system softwareRadiological healthUs drug enforcement administrationOffice of medicare hearingsPremarket submissions for device software functionsCenters for medicare medicaid servicesSoftware bill of materialsClinical decision support software

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