FDA Makes Draft Guidance Available on Lifecycle Management and Marketing Submission Recommendations for AI-Enabled Device Software Functions and Requests Industry Input
By EsqSocial Corporation 13/01/25
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Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations; Draft Guidance for Industry and Food and Drug Administration Staff” (Guidance). In it, the Center for Drug Evaluation and Research, the Center for Biologics Evaluation and Research, the Center for Device and Radiological Health, and the Office of Combination Products in the Office of the Commissions (FDA) jointly lay out proposed...
By: Faegre Drinker Biddle & Reath LLP