美国FDA数字健康创新行动计划介绍

U.S. FDA Digital Health Innovation Action Plan Introduction

为促进数字健康创新,确保患者从新技术中获益,美国FDA的器械和放射健康中心(CDRH)发布数字健康创新行动计划,阐述FDA为确保大众及时获得高质量、安全和有效的电子健康产品,提出新监管方法的计划。文章扼要介绍该计划的主要内容,供我国医疗器械监管部门和业界参考。

FDA’s Center for Device and Radiological Health issues Digital Health Innovation Action Plan, intending to advance the innovation of the digital health technology and ensure that patients beneft from new technologies. This document expounds the FDA？s plan to propose new regulatory approaches to ensure timely access to high-quality, safe and efective digital health products. This article briefy introduces the main contents of this plan for reference to the medical device supervision department and the industry in our country.