1. 新增2014/5/13 Ophthalmic Devices Panel of the Medical Devices Advisory Committee會議通知、2014/5/6-7Circulatory System Devices Panel of the Medical Devices Advisory Committee會議通知。

2. Premarket Approval (PMA) Summary Review Memos for 180-Day Design Changes:新增P950022/S085 Optisure High Voltage Lead Family

3. FDA Voice Blog新增「FDA Seeks Comment on Proposed Health IT Strategy That Aims to Promote Innovation」、「FDA Works with China to Ensure Medical-Product Safety」。

4. 公眾研討會:2014/5/13-15 Proposed Risk-Based Regulatory Framework and Strategy for Health Information Technology

5. 公告草案指引(Draft Guidance)Endotoxin Testing Recommendations for Single-Use Intraocular Ophthalmic Devices - Draft Guidance for Industry and Food and Drug Administration StaffLive Case Presentations During Investigational Device Exemption (IDE) Clinical Trials - Draft Guidance for Institutional Review Boards, Industry, Investigators, and Food and Drug Administration Staff

6. 新增2014/3/12 Microbiology Devices Panel of the Medical Devices Advisory Committee Meeting會議抄本、2014/3/20 Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee Meeting會議抄本。

7. Automatic Class III Designation (De Novo)新增K133883 Lyra Direct Strep Assay

8. FDA Safety Communication2014/4/17新增Laparoscopic Uterine Power Morcellation in Hysterectomy and Myomectomy

參考資料:

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

 

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