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Data Privacy › Data Management › Food and Drug Administration (FDA)

McDermott Will & Emery

FDA Reveals AI Development Cheat Sheet in Highly Anticipated Draft Guidances

McDermott Will & Emery on

Early in the new year, the US Food and Drug Administration (FDA) released two anticipated draft guidance documents focused on artificial intelligence (AI): Artificial Intelligence-Enabled Device Software Functions: Lifecycle...more

Faegre Drinker Biddle & Reath LLP

FDA Makes Draft Guidance Available on Lifecycle Management and Marketing Submission Recommendations for AI-Enabled Device Software...

Faegre Drinker Biddle & Reath LLP on

On January 7, 2025, FDA published “Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations; Draft Guidance for Industry and Food and Drug Administration Staff”...more

McDermott Will & Emery

Modernizing FDA’s Data Strategy: Agency Announces March 27 Public Meeting, Requests Written Comments by End of April

McDermott Will & Emery on

On January 7, 2020, the US Food and Drug Administration (FDA) announced that it will hold a public meeting on March 27 to discuss possible Agency-level approaches to modernizing FDA’s data strategy, including approaches to...more

McDermott Will & Emery

Disrupting Healthcare – Constructively: Considerations for Executing Innovation

McDermott Will & Emery on

The healthcare industry is facing significant disruption from new market entrants and technology innovations that have the potential to improve how care is delivered, to lower healthcare costs, and to improve healthcare...more

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