Classification is arguably one of the most important steps in the US FDA medical device approval process. Understanding how the US FDA classifies devices and the tools available to you is critical for identifying the proper regulatory pathway in the United States. Choosing the wrong device class could cost you considerable time and money, and result in regulatory or legal actions.
In this short video we cover the classes of medical devices, provide examples of navigating the classification database, discuss Product Codes and Regulation Numbers, and provide useful tips to consider as you research your device.
Understanding the US FDA Device Classification System
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How long will it take my 510(k) to be cleared by the US FDA?
Free online calculator provides average times the FDA takes to clear a product code for sale.
US FDA Registration Process for Medical Devices
Free flow chart provides a brief overview of how the PMA and the FDA 510(k) process work. The chart shown illustrates the FDA approval process in USA and is available for download in PDF format.
自2018年起，美国食品和药物管理局（U.S. Food and Drug Administration，FDA）开始试行以电子化方式来帮助行业提供完整的510(k)上市前通知。2022年，为推进以电子格式提供510(k)递交文件的过渡，美国FDA正式发布关于使用电子递交模板和资源的最终指导文
阅读更多预期用途是IVDR下公告机构核心讨论因素之一 新欧盟体外诊断医疗器械法规 (IVDR) (EU) 2017/746 实施了附件一“一般安全和性能要求”中的一项关键要求。该要求指明IVD器械“应达到制造商预期设定的性能要求，并应以在正常使用条件下适合其预期用途的方式进行设计和
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