M.D.'s Blogger

1. 公告2014年1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#