FDA向移动应用提出指导
根据最近的苹果报告此外,App Store上现已提供超过425,000个移动应用程序,令人惊慌的2亿用户和150亿个下载。和最近的报道显示使用Google的Android操作系统的爆炸性增长,每天有超过550,000个新激活。然而,移动应用的普遍存在的存在不仅限于游戏,因为糖尿病如糖尿病如糖尿病(近期ADA的时间超过700多个应用程序)。考虑到这一点,FDA最近发布了一份指导文件(原子能机构对特定主题的目前的思考)并不令人惊讶,详细介绍了如何将监管要求应用于某个移动应用程序的子集。原子能机构预期的准则留下了许多问题,但确实确认并扩展了诊断或治疗疾病的移动应用的监管框架,以及连接到其他医疗设备的应用。Where the FDA hasn’t yet claimed a regulatory role, but reserves the right to do so, is with apps that help people track and manage their health through data manually (or automatically) entered by the users, including identifying glucose patterns and improving overall management. One much-anticipated application for people with diabetes in this space is from Massive Health, a startup company currently running a closed beta test with iPhone users (Massive Health first opened the beta to diaTribe users and we advertised it on Twitter for 24 hours before it filled up – in the future, if you’d like to participate in chances like this, follow @diaTribenews and @MassiveHealth). From what we've seen of Massive Health's app, it seems easy to use, and even fun and entertaining. Other applications in this category offer treatment recommendations to patients, like WellDoc’s DiabetesManager (see新的现在下一步在诽谤#25)。General health and wellness apps (e.g., exercise suggestions, calorie counters, or “brochure ware,” like the new myMedtronic Connect app) will not be subject to FDA oversight or regulation.We’ve previously covered apps that will now clearly be regulated, such as AgaMatrix/Sanofi’s iBGStar (a self-contained blood glucose meter that plugs into the iPhone; see新的现在下一步在诽谤#25)。由于应用程序直接从医疗设备读取数据,因此在营销之前需要FDA批准。我们期待着帮助削减应用程序可能在未来问题中有助于糖尿病,他们的照顾者及其家人不同的应用程序。- ab / kc.