目前日期文章:201403 (4)

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 公告草案指引(Draft Guidance)Humanitarian Device Exemption (HDE): Questions and Answers - Draft Guidance for HDE Holders, Institutional Review Boards, Clinical Investigators, and Food and Drug Administration Staff

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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。

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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。

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1. 公告指引(Guidance)Requests for Feedback on Medical Device Submissions: The Pre-Submission Program and Meetings with Food and Drug Administration Staff - Guidance for Industry and Food and Drug Administration Staff

2. 消費者資訊公告[大眾場所置放自動體外心臟去顫器(Automated External DefibrillatorAED)之相關事項][病患升降機(Patient Lifts)之安全指引]

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