1. 新增2014/2/20 Anesthesiology and Respiratory Therapy Devices Panel of the Medical Devices Advisory Committee Meeting記錄抄本、2014/2/21 Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee Meeting記錄抄本、2014/3/12 Microbiology Devices Panel of the Medical Devices Advisory Committee Meeting摘要記錄、2014/3/14 Ophthalmic Devices Panel of the Medical Devices Advisory Committee Meeting摘要記錄、2014/3/20 Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee Meeting文字記錄。

2. 公告草案指引(Draft Guidance)Humanitarian Device Exemption (HDE): Questions and Answers - Draft Guidance for HDE Holders, Institutional Review Boards, Clinical Investigators, and Food and Drug Administration Staff

3. 公告201312月份PMA Final Decisions

4. Automatic Class III Designation (De Novo)新增K122566 Cefaly - Transcutaneous Electrical Nerve Stimulator

參考資料:

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

 

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