美国食品和药物管理局发布了人工智能医疗器械的新指导草案,强调安全性和透明度. FDA releases new draft guidance for AI medical devices, emphasizing safety and transparency.

美国食品和药物管理局已发布了针对人工智能医疗设备的新指导草案,计划于1月7日发布. The FDA has released new draft guidance for AI-enabled medical devices, scheduled for publication on January 7. 本指南旨在通过在产品生命周期(从设计到文件)中提出建议,支持安全有效的装置开发和营销。 This guidance aims to support safe and effective device development and marketing by providing recommendations through the product life cycle, from design to documentation. 它强调透明度、偏见管理和业绩监测。 It emphasizes transparency, bias management, and performance monitoring. 美国食品和药物管理局的数字健康卓越中心将在4月7日之前接受公众对该草案的意见. The FDA's Digital Health Center of Excellence will accept public comments on the draft until April 7. 此外,FDA 已发布了关于人工智能设备的市场后变化控制计划的最终指导,详细说明了制造商如何在没有额外的 FDA 授权的情况下更新设备,确保安全性和有效性. Additionally, the FDA has issued final guidance on Post-Market Changes Control Plans for AI devices, detailing how manufacturers can update devices without additional FDA authorization, ensuring safety and effectiveness.