1. 公告20141月份510(k) Final Decisions

2. 公告指引(Guidance)Annual Reports for Approved Premarket Approval Applications (PMA) - Guidance for Industry and Food and Drug Administration Staff

3. 公眾研討會:2014/2/26 FDA/AGS Workshop on Supporting Innovation for Safe and Effective Minimally Invasive Glaucoma Surgery

3. Automatic Class III Designation (De Novo)新增K123666 PillCam® COLON 2 Capsule Endoscopy System

4. 新增眼科器材小組2014/2/14 會議資料。

5. 公眾諮詢會議:2014/3/20 討論、建議及投票XVIVO Perfusion System (XPSTM) (sponsored by XVIVO Perfusion, Inc.)的人道醫療器材免除程序案(Humanitarian Device Exemption)

6. 公告指引(Guidance)Questions and Answers about eMDR - Electronic Medical Device Reporting - Guidance for Industry, User Facilities and FDA Staff

7. 法規研討會:2014/3/24 Regulatory Science and Sustainable Implementation of National and International Medical Device Registries

參考資料:

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

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