20180121 ECA新闻：FDA目前发布的医疗器械生产文件

20180121 ECA新闻：FDA目前发布的医疗器械生产文件

GMP News
21/01/2016

FDA's Current Publications for Manufacturers of Medical Devices

FDA目前发布的医疗器械生产文件

In irregular intervals, the ECA publishes overviews over new guidances or draft guidances, webinars, general strategy papers and inspection outcomes of the FDA with regard to medical devices. In the following, you will find a selection of the last 4 months.

ECA不定期地会公布FDA关于医疗器械的新指南或指南草案、培训、通用策略说明和检查结果的概览。在以下，你会看到最近4个月的情况。

In a detailed report made of 34 pages, the FDA explains its role in ensuring American patients have access to safe and effective medical devices. The report considers changes over the past five years.

在一份34页的详细报告里，FDA解释了其在确保美国患者使用安全有效医疗器械的方面的职责。报告考虑了在过去5年中发生的变化。

The FDA presents in 143 pages very extensively its recommendations for a national assessment system for medical devices. Among other things, it aims to build a bridge between research and clinical application.

FDA在143页中大量说明了其对医疗器械的合理评估系统建议。在其它内容中，其目的是在研究和临床应用中建立起一座桥梁。

We have already informed about the CDRHLearn in our News. Here again, new modules have been added to the respective webpage where presentations and slides of FDA representatives can be seen. Modules on post-market activities and on workshops about "Purchasing Controls", process validation as well as on CAPA have been newly added.

我们已经从我们的新闻中知道了CDERHLearn。这里，又将新的模块添加进了相应的网页中，其中可以看到FDA代表的演讲和幻灯。关于上市后销售行为和“采购控制”培训、工艺验证、以CAPA的模块被新增加了进去。

A very specific guideline draft entitled "General Considerations for Animal Studies for Medical Devices; Draft Guidance for Industry and Food and Drug Administration Staff" deals with the topic of animal testing in the course of the development of medical devices.

特定指南草案题为“医疗器械的动物研究中通常考虑”是关于医疗器械研发中动物测试的主题。

Within 34 pages, the very comprehensive guideline "eCopy Program for Medical Device Submissions" explains the handling of raw data in the course of electronic authorisations of medical devices.

在34页中，综合性指南“医疗器械申报的电子拷贝程序”解释了医疗器械电子批准中原始数据的处理。

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