Joy Sharp

Joy Sharp

Faegre Drinker Biddle & Reath LLP

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FDA Makes Draft Guidance Available on Lifecycle Management and Marketing Submission Recommendations for AI-Enabled Device Software...

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Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations; Draft Guidance for Industry and Food and Drug Administration Staff”...more

1/13/2025  /  Artificial Intelligence , Data Management , Data Privacy , Draft Guidance , Food and Drug Administration (FDA) , Machine Learning , Medical Devices , Regulatory Requirements , Risk Management

Race Against the Clock: Federal Agencies Issue Their Six-Month Updates on AI Activities in Accordance With President Biden’s...

Since President Biden issued his sweeping Executive Order on the Safe, Secure and Trustworthy Development of AI on October 30 of last year (EO), federal agencies have been operating in high gear to meet the deadlines and...more

5/3/2024  /  Artificial Intelligence , Department of Health and Human Services (HHS) , Draft Guidance , Life Sciences , NIST , U.S. Commerce Department , USPTO
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