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 公告草案指引(Draft Guidance)：Endotoxin Testing Recommendations for Single-Use Intraocular Ophthalmic Devices - Draft Guidance for Industry and Food and Drug Administration Staff、Live Case Presentations During Investigational Device Exemption (IDE) Clinical Trials - Draft Guidance for Institutional Review Boards, Industry, Investigators, and Food and Drug Administration Staff。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 Communication：2014/4/17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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