1. 公告指引(Guidance)Requests for Feedback on Medical Device Submissions: The Pre-Submission Program and Meetings with Food and Drug Administration Staff - Guidance for Industry and Food and Drug Administration Staff

2. 消費者資訊公告[大眾場所置放自動體外心臟去顫器(Automated External DefibrillatorAED)之相關事項][病患升降機(Patient Lifts)之安全指引]

3. 新增2013/12/11 Circulatory System Devices Panel of the Medical Devices Advisory Committee Meeting文字記錄。

參考資料:

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

 

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