IQVIA艾昆纬：2024年医疗器械监管提交的真实证据报告-深入了解美国食品药品监督管理局起草指南中的关键原则，以评估现实世界数据对监管决策的相关性和可靠性（英文版）

In December 2023, the FDA issued a draft guidance document titled “Use of RWE to Support Regulatory Decision-Making for Medical Devices.” This update builds upon their original guidance issued in 2017. Given the rapid technological advancements within MedTech, including our improved capacity to access and curate real world data (RWD), the FDA’s release of this guidance document is timely and important. This guidance document addresses the growing need to utilize RWD to inform regulatory decision