1. 新增2014/3/26-27 Molecular and Clinical Genetics Panel of the Medical Devices Advisory Committee Meeting的摘要。

2. 新增P130015[Elecsys® HBeAg Immunoassay and Elecsys® PreciControl HBeAg](HBeAg免疫系統)-使用者資訊及產品摘要資訊。

3. FDA Voice Blog新增「FDA Wants Your Perspective on Clinical Trial Demographic Data」。

4. 公告指引(Guidance)Types of Communication During the Review of Medical Device Submissions - Guidance for Industry and Food and Drug Administration Staff

參考資料:

U.S. FDA CDRHNews http://www.fda.gov/MedicalDevices/NewsEvents/News/default.htm#

 

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