M.D.'s Blogger

1. 公眾諮詢會議：2014/6/17舉行[Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee Meeting Announcement]，討論、建議及投票PMA [the Maestro® Rechargeable System sponsored by Enteromedics, Inc.]，本器材藉由非侵入式生理治療去減輕體重，並不會改變消化系統結構，進一步改善生活及食物選擇。

2. 新增P120020[Supera Peripheral Stent System](周邊血管支架系統)-使用者資訊及產品摘要資訊。

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。

1. Automatic Class III Designation (De Novo)新增K080644 AirPurge System。

2. 為了符合Unique Device Identification (UDI)要求，公告停止發行National Health Related Items Code (NHRIC) and National Drug Code (NDC) labeler codes給醫療器材廠商。

1. 新增2014/3/26-27 Molecular and Clinical Genetics Panel of the Medical Devices Advisory Committee Meeting的摘要。

2. 新增P130015[Elecsys® HBeAg Immunoassay and Elecsys® PreciControl HBeAg](HBeAg免疫系統)-使用者資訊及產品摘要資訊。

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 公告草案指引(Draft Guidance)：Premarket Notification [510(k)] Submissions for Bipolar Electrosurgical Vessel Sealers for General Surgery、Premarket Assessment of Pediatric Medical Devices -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

2014/4/18 2014奈米化醫療器材相關之安全性及風險評估機制探討-業界說明會(僅供參考，不以商業宣傳為目的)

2014/4/25、5/6醫療器材基本規範（EP）及技術文件摘要(STED)法規推廣教育訓練課程(僅供參考，不以商業宣傳為目的)

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 公告草案指引(Draft Guidance)：Humanitarian Device Exemption (HDE): Questions and Answers - Draft Guidance for HDE Holders, Institutional Review Boards, Clinical Investigators, and Food and Drug Administration Staff。

1. 新增2014/3/12 Microbiology Devices Panel of the Medical Devices Advisory Committee Meeting文字記錄、2014/3/14 Ophthalmic Devices Panel of the Medical Devices Advisory Committee Meeting文字記錄。

2. 公眾諮詢會議：2014/4/1舉行[Advancing Regulatory Science for High Throughput Sequencing Devices for Microbial Identification and Detection of Antimicrobial Resistance Markers]，公開討論臨床和公共健康應用及這些產品的效能確效，以建立法規上可參考資料的準確度及標準。

1. 新增2014/2/20 Anesthesiology and Respiratory Therapy Devices Panel Meeting的摘要。

2. 新增P120005/S002[Dexcom G4 PLATINUM (Pediatric) Continuous Glucose Monitoring System](持續血糖監測系統)-使用者資訊及產品摘要資訊。