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一、 一般指引

1.        Format for Traditional and Abbreviated 510(k)s - Guidance for Industry and FDA Staff

[傳統與簡化510(k)的格式] September, 2019

 

2.        Guidance for Industry and Food and Drug Administration Staff - Refuse to Accept Policy for 510(k)s

[510(k)拒絕接受政策] September, 2019

 

3.        The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)] - Guidance for Industry and Food and Drug Administration Staff

[510(k)程序：在上市前通知 [510(k)] 中評估實質相等性] July, 2014

 

4.        Medical Device Tracking - Guidance for Industry and Food and Drug Administration Staff

[醫療器材追蹤] March, 2014

 

5.        Mobile Medical Applications - Guidance for Industry and Food and Drug Administration Staff

[行動醫療應用程式 (apps)] September, 2019

 

6.        Guidance for Industry and Food and Drug Administration Staff - eCopy Program for Medical Device Submissions

[針對醫療器材申請的eCopy計畫] April, 2020

 

7.        Medical Device Classification Product Codes - Guidance for Industry and Food and Drug Administration Staff

[醫療器材產品分類分級代碼] April, 2013

 

8.        Guidance for Industry and Food and Drug Administration Staff - User Fees and Refunds for Premarket Notification Submissions (510(k)s)

[上市前通知(510(k)s)的費用與退款] October, 2017

  

9.      Application of the Device Good Manufacturing Practice (GMP) Regulation to the Manufacture of Sterile Devices

[器材優良製造規範(GMP)－無菌器材製造規範] December, 1983

 

10.       Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process"

[醫療器材生物性評估Part 1：風險管理中的評估與測試流程] September,, 2020

 

11.       Design Control Guidance for Medical Device Manufacturers

[給醫療器材製造商的設計控制導引] March, 1997

 

12.       Device Labeling Guidance #G91-1 (blue book memo)

[器材標籤導引 #G91-1(blue book memo)] March, 1991

 

13.       Programs Branched from the New Paradigm 510(k) in 2019

The Abbreviated 510(k) Program – Guidance for Industry and FDA Staff

[簡化510(k)的格式] September, 2019

The Special 510(k) Program – Guidance for Industry and FDA Staff

[特殊510(k)的格式] September, 2019

 

14.      General Principles of Software Validation

[軟體確認的一般守則] January, 2002

 

15.      Investigational Device Exemptions (IDEs) for Early Feasibility Medical Device Clinical Studies, Including Certain First in Human (FIH) Studies

[針對早期可行性醫療器材臨床研究的IDE申請] October, 2013

 

16.      Guideline on General Principles of Process Validation

[程式確效一般準則導引] January, 2011

 

17.      Labeling - Regulatory Requirements for Medical Devices (FDA 89-4203)

[標籤-醫療器材規範要求(FDA 89-4203)] September, 1989

 

18.      Medical Device Reporting for Manufacturers

[給製造商的醫療器材報告] November, 2016

 

19.      Shelf Life of Medical Devices

[醫療器材之置架期] April, 1991

 

20.     Guidance for Industry and FDA Staff - The Review and Inspection of Premarket Approval Application Manufacturing Information and Operations

[製造業上市前核可申請資訊與操作之審查檢測] January, 2008

 

二、個別器材指引

21.      Overview of IVD Regulation

[體外診斷器材法規概要]

 

22.      In Vitro Companion Diagnostic Devices 

[體外協同診斷器材] August, 2014

 

23.     510(k) Information Needed for Hydroxyapatite Coated Orthopedic Implants  

[羥基磷灰石塗層外科植入所需510(k)資訊] February, 1997

 

24.     Guidance Document for the Preparation of Premarket Notification [510k)] Applications for Mechanical and Powered Wheelchairs, and Motorized Three-Wheeled Vehicles 

[上市前通知510(k)申請準備之導引文件－機械電動輪椅以及電動三輪車] July, 1995

 

25.      Biological Indicator (BI) Premarket Notification [510(k)] Submissions

[生物指示劑的上市前通知510(k)申請] October, 2007

 

26.     Class II Special Controls Guidance Document: Electrocardiograph Electrodes-Guidance for Industry and Food and Drug Administration Staff  

[給各企業及FDA職員－二類器材特殊控制導引文件：心電圖用電極] July, 2011

 

27.     Class II Special Controls Guidance Document: Endotoxin Assay - Guidance for Industry and FDA Staff

[二類器材特殊控制導引文件：內毒素測定] October, 2003

 

28.     Clinical Data Presentations for Orthopedic Device Applications - Guidance for Industry and FDA Staff

[整形外科器材申請的臨床檔案呈現] December, 2004

 

29.     Class II Special Controls Guidance Document: Dental Bone Grafting Material Devices - Guidance for Industry and FDA Staff

[二類器材特殊控制導引文件：牙科骨移植材料器材] April, 2005

 

30.     Dental Curing Lights - Premarket Notification [510(k)]

[牙科光固化機－上市前通之510(k)申請] March, 2006

 

31.     Diagnostic ECG Guidance (Including Non-Alarming ST Segment Measurement) - Guidance for Industry

[心電圖診斷導引(包括無警報ST段測量)] November, 1998

 

32.     Suggested Format for IDE Progress Report

[IDE進度報告建議格式] June, 1996

 

33.     Guidance Document for Dura Substitute Devices - Guidance for Industry

[人工腦膜替代品導引文件；給企業的導引] November, 2000

 

34.     Guidance Document for Powered Muscle Stimulator 510(k)s - Guidance for Industry, FDA Reviewers/Staff and Compliance

[電動肌肉刺激器510(k)導引文件] June, 1999

 

35.     Guidance Document for Testing Biodegradable Polymer Implant Devices

[生物降解聚合物植入性器材測試之導引文件] April, 1996

 

36.     Abbreviated 510(k) Submissions for In Vitro Diagnostic Calibrators

[體外診斷校準器之簡化510(k)申請] February, 1999

 

37.     Immunotoxicity Testing Guidance

[毒性免疫測試導引] May, 1999

 

38.     Non-Clinical Engineering Tests and Recommended Labeling for Intravascular Stents and Associated Delivery Systems - Guidance for Industry and FDA Staff

[血管支架以及相關輸送系統之非臨床試驗與推薦標籤] April, 2010

 

39.     Guidance for Studies for Pain Therapy Devices - General Consideration in the Design of Clinical Studies for Pain-Alleviating Devices

[疼痛療法器材-疼痛舒緩臨床研究設計之整體考量] May, 1988

 

40.     Class II Special Controls Guidance Document:Polymethylmethacrylate (PMMA) Bone Cement- Guidance for Industry and FDA

[二類器材特殊控制導引文件：聚甲基丙烯基甲酯(PMMA)骨水泥] July, 2002

 

41.     Acceptance and Filling Reviews for Premarket Approval Application (PMAs)

[上市前核准申請歸檔審查] December, 2019

 

42.     Guidance Document for the Preparation of Premarket Notification [510(k)] Applications for Heating and Cooling Devices

[加熱與冷卻器材之上市前通知510(k)申請] July, 1995

 

43.     Radio Frequency Wireless Technology in Medical Devices - Guidance for Industry and FDA Staff

[醫療器材之射頻無線技術] August, 2013

 

44.     Class II Special Controls Guidance Document: Resorbable Calcium Salt Bone Void Filler Device - Guidance for Industry and FDA

[二類器材特殊控制導引文件：再吸收鈣鹽骨洞填充裝置－給各企業和FDA職員的導引]  June, 2003

 

45.     Review Guidance for Oxygen Generators and Oxygen Equipment

[製氧機與氧氣裝置的審查導引] January, 1977

 

 46.     Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments - Guidance for Industry and FDA Staff

[二類器材特殊控制導引文件：根型骨內植體與牙科骨內植體基台] May, 2004

 

47.     Class II Special Controls Guidance: Shoulder Joint Metal/Polymer/Metal Nonconstrained or Semi-Constrained Porous-Coated Uncemented Prosthesis-Guidance for Industry and FDA Staff 

[二類器材特殊規範導引文件：肩關節金屬類/聚合物類非限制型多孔塗佈無骨水泥式彌補物] October, 2000

 

48.     Class II Special Controls Guidance Document: Topical Oxygen Chamber for Extremities - Guidance for Industry and FDA Staff

[二類器材特殊規範導引文件：四肢用氧氣艙－給各企業和FDA職員的導引] April, 2011

 

49.     Dental Handpieces - Premarket Notification [510(k)] Submissions

 [牙科手機-上市前通告510(k)申請] May, 2007