FDA发布关于处方药应用程序和软件的最终指南
正文 · 中文译文
美国食品药品监督管理局（FDA）新闻稿 FDA发布关于处方药应用程序（app）和软件的最终指南 新政策明确了应用程序内容何时需要接受FDA审查，以及与药物相关联的软件在药品标签上必须如何描述 更多新闻公告 即时发布： 2026年10月20日 美国食品药品监督管理局今日发布最终指南，为制药公司如何开发、分发与其处方药配合使用的应用程序以及对这类应用程序进行标注建立了一个清晰的框架。该指南通过就应用程序内容何时须遵守FDA的提交要求、何时应在药品官方标签中提及某一应用程序、以及公司应向该机构提交哪些内容提供建议，终结了长期存在的不确定性。 “移动应用程序在患者管理其用药和健康状况方面正发挥着越来越重要的作用，”FDA药品评价与研究中心医学政策项目处（Division of Medical Policy Programs）处长、上校（Captain）、药学博士（Pharm.D.）Chris Wheeler表示，“本指南有助于确保这些工具所提供的信息准确、循证，并能清晰地传达给患者及其医疗服务提供者。” 该指南针对行业解答了三个关键问题：应用程序内容何时被作为FDA要求的标签而非宣传性标签对待；何时应在药品的官方处方信息中提及某一应用程序；以及当公司向用户分发应用程序内容时应向FDA提交什么。 该指南确定了伴随软件（companion software）的两个类别： 与医疗器械连接的应用程序（例如与哮喘吸入器配对的应用程序）通常应在药物的官方处方标签中予以说明，因为该软件在药物的使用方式中发挥着核心作用。 独立应用程序（如症状追踪器、剂量提醒或健康指导工具）如果公司能够证明该应用程序对安全有效使用至关重要，或能够证明其具有显著的临床获益，则应出现在处方标签上。在大多数情况下，配套应用程序向用户显示的内容将被视为促销材料，这与FDA处理其他药物广告的方式一致。 “该指南反映了FDA对数字健康进行负责任、与风险相称的监管的承诺。数字健康是该机构的一个关键优先领域，发展迅速，并为改善患者护理具有重大前景，”FDA药物评价与研究中心主任Michael Davis医学博士、哲学博士表示。“通过协调药物和器械中心的方法，我们为开发者提供了一条清晰且一致的路径，将安全有效的数字健康技术带给患者。” “配套应用程序正迅速从简单的剂量提醒发展为适应每位患者的工具，”FDA技术事务副局长Jared Seehafer理学硕士表示。“完成该指南的定稿，为制药公司及其技术合作伙伴随着这些技术的进步提供了稳定的基础，并有助于确保患者和提供者能够信任他们获得的信息。” 本指导文件亦体现了FDA持续致力于现代化其监管框架，以跟上快速发展的数字健康技术的步伐。通过为药物关联软件和独立软件提供清晰、实用的建议，该机构旨在减少开发者和制造商面临的不必要不确定性，同时保持患者和医疗服务提供者所依赖的安全性和有效性标准。 最终指导文件可在此处获取。 媒体： FDA征求意见 202-690-6343 消费者： 888-INFO-FDA ### 标准文本 FDA是美国卫生与公众服务部下属机构，通过确保人用和兽用药物、疫苗及其他人类生物制品和医疗器械的安全性、有效性和安全性来保护公众健康。该机构还负责我国食品供应、化妆品、膳食补充剂、辐射发射电子产品的安全和保障，以及烟草制品的监管。 内容最新更新时间： 2026年10月20日 受监管产品 药品 关注FDA 在X上关注@US_FDA 在Facebook上关注FDA 在X上关注@FDAMedia
正文 · 英文原文
FDA News Release FDA Issues Final Guidance on Prescription Drug Apps and Software New policy clarifies when app content requires FDA review and how drug-connected software must be described on medication labels More Press Announcements For Immediate Release: October 20, 2026 The U.S. Food and Drug Administration today released final guidance establishing a clear framework for how drug companies can develop, distribute, and label apps used alongside their prescription medicines. The guidance ends longstanding uncertainty by providing recommendations about when app content is subject to FDA submission requirements, when an app should be mentioned on a drug’s official label, and what companies should submit to the agency. “Mobile apps are playing a growing role in how patients manage their medications and health conditions,” said Captain Chris Wheeler, Pharm.D., Director of the Division of Medical Policy Programs within FDA’s Center for Drug Evaluation and Research. “This guidance helps ensure that the information these tools provide is accurate, evidence-based, and clearly communicated to both patients and their providers.” The guidance addresses three key questions for industry: when app content is treated as FDA-required labeling versus promotional labeling, when an app should be referenced in a drug’s official prescribing information, and what companies should submit to FDA when they distribute app content to users. The guidance identifies two categories of companion software: Apps connected to a medical device (such as an app paired with an asthma inhaler) generally should be described on the drug’s official prescribing label, given the central role the software plays in how the medicine is used. Standalone apps (such as symptom trackers, dose reminders, or health coaching tools) should appear on the prescribing label if the company can show the app is essential for safe and effective use or can demonstrate a meaningful clinical benefit. In most cases, content a companion app displays to users will be treated as promotional material, consistent with how the FDA handles other drug advertising. “This guidance reflects FDA’s commitment to responsible, risk-proportionate oversight of digital health, an area that is a key priority for the agency and is evolving rapidly and holds significant promise for improving patient care,” said Michael Davis, M.D., Ph.D., Director of the FDA’s Center for Drug Evaluation and Research. “By aligning our approach across drug and device centers, we are giving developers a clear and consistent pathway to bring safe, effective digital health technologies to patients.” “Companion apps are quickly moving beyond simple dose reminders toward tools that adapt to each patient,” said Jared Seehafer, M.S., FDA Deputy Commissioner for Technology. “Finalizing this guidance gives drug companies and their technology partners a stable foundation to build on as these technologies advance and helps ensure patients and providers can trust the information they receive.” This guidance also reflects the FDA’s ongoing commitment to modernizing its regulatory framework to keep pace with rapidly evolving digital health technologies. By providing clear, practical recommendations for both drug-connected software and standalone software, the agency aims to reduce unnecessary uncertainty for developers and manufacturers while preserving the safety and effectiveness standards that patients and healthcare providers rely on. The final guidance is available here. Media: FDA Request for Comment 202-690-6343 Consumer: 888-INFO-FDA ### Boilerplate The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation's food supply, cosmetics, dietary supplements, radiation-emitting electronic products, and for regulating tobacco products. Content current as of: 10/20/2026 Regulated Product(s) Drugs Follow FDA Follow @US_FDA on X Follow FDA on Facebook Follow @FDAMedia on X