1. 公告Medical Device Recall, FY2003-FY2012

2. 公告草案指引(Draft Guidance)Premarket Notification [510(k)] Submissions for Bipolar Electrosurgical Vessel Sealers for General SurgeryPremarket Assessment of Pediatric Medical Devices - Guidance for Industry and Food and Drug Administration StaffMedical Device Tracking - Guidance for Industry and Food and Drug Administration Staff

3. 消費者資訊公告[對抗糖尿病的指引說明]

參考資料:

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

 

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