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China Agrees to Cut Tariffs on U.S. Medical Devices Read More

The U.S. Food and Drug Administration (FDA) has released a guidance document to better clarify the regulatory processes for molecular diagnostic devices, especially those that can be used for multiple unrelated assays. This includes both approved or cleared functions — such as... Read More

The developing world is experiencing more Western diseases as they consume more Western products such as fast food, leading to a rise in the cardiology, orthopedics, and cancer rates. This means that the developing world is seeing a growing demand for devices... Read More

美国食品药品监督管理局（U.S. Food and Drug Administration；FDA）发布了几份重要文件。2014年9月16日，FDA发布了关于新药简略申请（abbreviated new drug application；ANDA）的指导原则的最终稿，此文件解释了有可能导致FDA拒绝接收某一个ANDA的几种具体申请缺陷。FDA也发布了一份指导文件草案,概述了各种由于杂质限度确定不恰当而导致ANDA申请不被批准的原因。 Read More

The U.S. Food and Drug Administration (FDA) has released several important documents. On September 16, 2014, the FDA released a final guidance for abbreviated new drug applications (ANDAs), explaining a variety of specific application deficiencies that may result in the FDA refusing... Read More

美国食品和药物管理局（FDA）有几个试点项目正在进行中，应该使许多医疗器械的注册申请更加简单和快捷。对于上市前通知，510（K）电子申请（eSubmissions）计划将引导企业将申请文件合并，并提交510（k）申请- 可加快审评进程。该试点项目，于2014年7月开始，正在迅速扩大。该计划最终将覆盖更多类型的医疗器械申请，包括上市前批准（PMA）申请。 Read More

The U.S. Food and Drug Administration (FDA) has several pilot programs underway that should make many medical device applications simpler and faster. For premarket notifications, the 510(k) eSubmissions Program will guide companies in putting together and submitting a 510(k) application -- resulting... Read More

2014年8月1日，美国食品和药物管理局（FDA）宣布2015年的制药和医疗设备申请费。 这些费率将在2014年10月1日至2015年9月30日有效。对于医疗器械，上市前申请（PMA）将耗资250，895美元；510（K）上市前通知将提高到5018美元。 Read More

On August 1, 2014, the U.S. Food and Drug Administration (FDA) announced the fiscal year 2015 user fees for pharmaceutical and medical device companies. These rates will be effective from October 1, 2014 through September 30, 2015. For medical devices, a premarket... Read More

In late June 2014, the FDA released a draft guidance entitled Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communications Devices. The guidance announced that these types of systems and devices would no longer need to comply with some... Read More