Recently-Approved Devices 510(k) Clearances PMA Approvals进入相应项,即可搜索查询 Recently-Approved Devices 510(k) Clearances PMA Approvals 国内正在注册的体外诊断试剂,在FDA上市的情况https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Databases/default.htm 510k文件有些查询结果这里可以直接下载。
List of Cleared or Approved Companion Diagnostic Devices (In Vitro and Imaging Tools) Drug Trade Name (Generic Name) Erbitux (cetuximab); BLA 125084; DAKO EGFR PharmDx Kit P030044S001-S002 Dako North America, Inc. The EGFR pharmDx? assay is a qualitative immunohistochemical (IHC) kit system ...
The present analysis demonstrates that most of the medical devices recalled by the FDA owing to serious risks during the past 5 years were approved through the 510(k) regulatory process or were completely exempt from regulatory review (78%). As such, these devices did not undergo clinical testi...
andnonprescription drugs without approved new drug applications which are governedby the provisions of section 505G of the FD&C Act (often referred to asover-the-counter (OTC) monograph drugs4). These
1. FDA批准数据库(FDA Approved Database):该数据库提供了FDA批准的药品、医疗器械、食品添加剂等产品的详细信息。您可以通过产品名称、活性成分、应用领域等进行搜索。访问链接:https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm 2. FDA医疗器械数据库(FDA Medical Device Database):该数据库提供了FDA...
recommendations onoptimizing respirator use, please visit CDC’s webpage: Strategiesfor Optimizing the Supply of N95 Respirators. Please note that thislist is updated on a rolling basis as new information becomesavailable for FDA to review. Authorized Imported, Non-NIOSHApproved Respirators ...
Getting Your Medical Device FDA Approved
For additional information regarding annual reports, refer to the FDA guidance document “Annual Reports for Approved Premarket Approval Applications (PMA).”19 If a 30 day-day notice contains device design or labeling changes in addition to manufacturing changes, then the submission will automatically...
For investigational drug studies, clinical investigators must retain study records for a period of two years following the date a marketing application is approved for the drug for the indication for which it is being investigated; or, if no application is to be filed or if the application is ...
4月3日,美国FDA官方网站(fda.gov/)发布了针对中国生产的未获NIOSH认证的呼吸器(口罩)获得EUA授权的文件(Non-NIOSH-Approved Disposable Filtering Facepiece Respirators Manufactured in China)。 原文地址:fda.gov/media/136664/do 标红部分的内容翻译(本文翻译部分源自检测微信公众平台)1、由拥有一个或多个NIOSH认...