NEW FDA DRAFT GUIDANCE ON AI-ENABLED MEDICAL DEVICES PUBLISHED
Rockville, MD — On January 7, 2025 — The Food and Drug Administration (FDA) published a landmark draft guidance titled “Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations“. This document provides a comprehensive roadmap for manufacturers to navigate the regulatory requirements for AI-enabled medical devices across their entire lifespan, marking a significant […]
THE NEW FDA DRAFT GUIDANCE FOR EMERGENCY DIAGNOSTICS
United States, January 7, 2025 — The FDA has officially released a comprehensive draft guidance titled “Validation of Certain In Vitro Diagnostic Devices for Emerging Pathogens During a Section 564 Declared Emergency“. This document marks a pivotal shift in how the Agency expects manufacturers to validate In Vitro Diagnostic (IVD) devices when time is of […]