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Software › Risk Assessment › Machine Learning

Hogan Lovells

New guidance on AI-enabled device software functions clarifies information FDA expects in marketing applications

Hogan Lovells on

On January 7, 2024, the U.S. Food and Drug Administration (FDA) published the draft guidance “Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations,” which...more

King & Spalding

FDA Releases Draft Guidance on Submission Recommendations for AI-Enabled Device Software Functions

King & Spalding on

On January 7, 2025, FDA published a draft guidance titled “Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations.” The draft guidance was long-anticipated; it...more

Alston & Bird

What to Tell Your C-Suite About the EU AI Act

Alston & Bird on

Our Privacy, Cyber & Data Strategy Team highlights 11 common questions your company’s senior executives may have about the European Union’s Artificial Intelligence Act and how you can answer them....more

ArentFox Schiff

Artificial Intelligence in the Family Office: Risks and Rewards

ArentFox Schiff on

Generative artificial intelligence (AI) is computer software that can create new content or data by tracking patterns from existing data. AI is dominating public discourse: across all media, all industries, and all segments...more

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