Regulatory Affairs Professionals Society· @RAPSorg · X·· 2026-04-25精选AI 评分62
AI 导读
FDA与CMS提出一项平行审评计划，名为Regulatory Alignment for Predictable and Immediate Device（RAPID）覆盖路径，旨在加快部分II类和III类突破性医疗器械上市，使Medicare患者更快获得这些器械。相关详情见链接：https://hubs.la/Q04dr9-p0。
推荐理由
FDA与CMS联合提出RAPID平行审评路径，读者可了解突破性器械在上市与医保覆盖上的同步机制。
正文
FDA and CMS have proposed a parallel review program to expedite certain Class II and Class III breakthrough medical devices to market for Medicare patients called the Regulatory Alignment for Predictable and Immediate Device (RAPID) coverage pathway. https://hubs.la/Q04dr9-p0
来源：Regulatory Affairs Professionals Society · x.com