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 公告草案指引(Draft Guidance):Humanitarian Device Exemption (HDE): Questions and Answers - Draft Guidance for HDE Holders, Institutional Review Boards, Clinical Investigators, and Food and Drug Administration Staff。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2013年12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#