FDA发布 射频无线技术在医疗器械应用指导
来源:    发布时间: 2013-07-25 13:52   7042 次浏览   大小:  16px  14px  12px
FDA发布 射频无线技术在医疗器械应用指导

射频无线技术在我们的社会正变得越来越普遍,包括其在医疗保健行业,并在新的医疗设备的发展。今天,美国食品和药物管理局(FDA)发出的 无线电频率,无线技术在医疗器械工业和食品药品监督管理局人员指导 。美国食品和药物管理局发出这最后的指导,协助行业和FDA工作人员的设计,测试,部署,监管意见书,可靠,安全,有效的无线电频率的无线医疗设备和系统的维护。


美国食品和药物管理局还推出了“无线医疗设备”网页T O提供资源,共同考虑促进射频无线技术应用于医疗器械的安全性和有效性。我们相信,这些信息将继续推进令人振奋的进步技术采取了进一步的医疗保健人员,患者和消费者.


Radio frequency wireless technology is becoming increasingly prevalent in our society, including its use in the health care industry and in the development of new medical devices. Today the Food and Drug Administration (FDA) issued the Radio Frequency Wireless Technology in Medical Devices Guidance for Industry and Food and Drug Administration Staff.  The FDA is issuing this final guidance to assist industry and FDA staff with the design, testing, deployment, regulatory submission, and maintenance of reliable, safe, and effective radio frequency wireless medical devices and systems.


The FDA also launched a "Wireless Medical Devices" web page to provide resources and common considerations to promote the safety and effectiveness of radio frequency wireless technology used in medical devices.  We believe this information will continue to promote the exciting strides technology has taken to further health care for providers, patients, and consumers.