FDA常用指南文件清单

未名123

FDA指南清单
序号	中文文件名称	原文文件名称
1	上市前批准申请模块审核	Premarket Approval Application  Modular Review
2	医疗器械的电子副本提交程序	eCopy Program for Medical Device  Submissions
3	上市前批准申请中制造信息和运营的审查与检查	The Review and Inspection of  Premarket Approval Application Manufacturing Information and Operations
4	无菌类器械上市前通告(510(k))申报中关于无菌证明资料的提交及审查	Submission and Review of  Sterility Information in Premarket Notification (510(k)) Submissions for  Devices Labeled as Sterile
5	电池指南	Battery Guidelines
6	着色剂申请	Color Additive Petitions
7	移动医疗的应用	Mobile Medical Applications
8	设备标签指南	Device Labeling Guidance
9	免疫毒性试验指南	Immunotoxicity Testing Guidance
10	软件验证的一般原则	General Principles of Software  Validation
11	现成医疗器械软件的使用	Off-The-Shelf Software Use in  Medical Devices
12	医疗设备和EMI：FDA观点	Medical Devices and EMI: The FDA  Perspectiv
13	儿科用医疗器械的上市前评估	Premarket Assessment of  Pediatric Medical Devices
14	一般健康：低风险设备的政策	General Wellness: Policy for Low  Risk Devices
15	含乳胶的医疗器械标注乳胶标识	The labels of certain medical  devices to declare latex content
16	无线医疗遥测的风险和建议	Wireless Medical Telemetry Risks  and Recommendations
17	含有防锐器损伤特性的医疗器械	Medical Devices with Sharps  Injury Prevention Features
18	医疗器械关键临床研究的设计考虑因素	Design Considerations for  Pivotal Clinical Investigations for Medical Devices
19	医疗器械临床研究中特定性别数据的评价	Evaluation of Sex-Specific Data  in Medical Device Clinical Studies
20	医疗器械网络安全管理的上市前提交内容	Content of Premarket Submissions  for Management of Cybersecurity in Medical Devices
21	保护性限制的上市前通知提交的内容指南	Guidance On the Content Of  Premarket Notification [510(K)] Submissions for Protective Restraints
22	含现有（OTS）软件的网络化医疗设备的网络安全	Cybersecurity for Networked  Medical Devices Containing Off-the-Shelf (OTS) Software
23	应用人为因素和可用性工程优化医疗器械设计	Applying Human Factors and  Usability Engineering to Medical Devices
24	对于含有软件的医疗器械的上市前申请内容的指南	Guidance for the Content of  Premarket Submissions for Software Contained in Medical Devices
25	加工、再加工医疗器械的医疗关键点：验证方法和标识	Reprocessing Medical Devices in  Health Care Settings: Validation Methods and Labeling
26	认定510（k）器械预期用途；CDRH工作人员指南（更新至K98-1）	Determination of Intended Use  for 510(k) Devices; Guidance for CDRH Staff (Update to K98-1)
27	含有天然橡胶器械的用户标识（21 CFR  801.437）；小型实体合规指南	User Labeling for Devices that  Contain Natural Rubber (21 CFR 801.437); Small Entity Compliance Guide
28	医疗设备数据系统、医疗图像存储设备和医疗图像通信设备	Medical Device Data Systems,  Medical Image Storage Devices, and Medical Image Communications Devices
29	用于告知用户产品或产品容器并非由天然胶乳制成的医疗产品标识建议	Recommendations for Labeling  Medical Products to Inform Users that the Product or Product Container is not  Made with Natural Rubber Latex
30	国际标准ISO-10993，"医疗器械的生物学评价第1部分：评价和检验"的使用	Use of International Standard  ISO-10993, "Biological Evaluation of Medical Devices Part 1: Evaluation  and Testing"
31	医疗器械早期可行性临床研究（包括首次应用于人类研究）的器械临床研究豁免（IDE）	Investigational Device  Exemptions (IDE) for Early Feasibility Medical Device Clinical Studies,  Including Certain First in Human (FIH) Studies
32	《关于在卫生保健机构中使用的灭菌器上市前通知[510（k）]提交资料意见的指南》附录	Addendum to: Guidance on  Premarket Notification [510(k)] Submissions for Sterilizers Intended for Use  in Health Care Facilities
33	通信系统（动力和非动力）和动力环境控制系统准备上市前通知[510（k）]申请的指南	Guidance Document for The  Preparation of Premarket Notification [510(K)] Applications for  Communications Systems (Powered and Non-Powered) and Powered Environmental  Control Systems
34	医疗器械有效期	Shelf Life of Medical Devices
35	医疗器械申请资料审核期间的沟通类型	Types of Communication During  the Review of Medical Device Submissions
36	在美国境外实施研究所获得医疗器械临床数据的验收	Acceptance of Medical Device  Clinical Data from Studies Conducted Outside the United States
37	医疗器械上市前申请自愿共识标准的合理使用	Appropriate Use of Voluntary  Consensus Standards in Premarket Submissions for Medical Devices
38	评估用户费用：PMA补充申请定义、模块化PMA费用、BLA和功效补充申请定义、一份申请中捆绑多个器械以及组合产品的费用	Assessing User Fees PMA  Supplement Definitions, Modular PMA Fees, BLA and Efficacy Supplement  Definitions, Bundling Multiple Devices in a Single Application
39	平衡需接受上市前审批的器械的上市前和上市后数据收集行业及美国食品药品管理局工作人员指南	Balancing Premarket and  Postmarket Data Collection for Devices Subject to Premarket Approval-Guidance  for Industry and Food and Drug Administration Staff
40	决定具备不同技术特征器械的上市前通知[510（k）]实质等同性中需考虑的效益和风险因素	Benefit-Risk Factors to Consider  When Determining Substantial Equivalence in Premarket Notifications [510(k)]  with Different Technological Characteristics
41	CDRH有关待认可候选共识标准的识别和评价的标准操作程序	CDRH Standard Operating  Procedures for the Identification and Evaluation of Candidate Consensus  Standards for Recognition
42	重新审理分类过程（III类器械自动命名评估）	De Novo Classification Process  (Evaluation of Automatic Class III Designation)
43	何时为现有器械变更申报510 (k)的决定	Deciding When to Submit a 510(k)  for a Change to an Existing Device
44	交互操作医疗器械的设计考量和上市前提交建议	Design Considerations and  Pre-market Submission Recommendations for Interoperable Medical Devices
45	医疗器械生产商的设计控制指南	Design Control Guidance For  Medical Device Manufacturers.pdf
46	临床研究者财务披露	Guidance for Clinical  Investigators, Industry, and FDA Staff-Financial Disclosure by Clinical  Investigators.pdf
47	机构审查委员会（IRB）指南-常见问题 – IRB 注册	Guidance for Institutional  Review Boards (IRBs)- Frequently Asked Questions – IRB Registration.pdf
48	关于接收非实质等同性（NSE）信函的再处理一次性使用器械（SUD）状况的常见问题（FAQ）	Frequently Asked Questions  (FAQs) on the Status of Reprocessed Single Use Devices (SUDs) that receive a  Not Substantially Equivalent (NSE) Letter.pdf
49	共识标准认可的常见问题	Frequently Asked Questions on  Recognition of Consensus Standards.pdf
50	医疗器械动物研究总则	General Considerations for  Animal Studies for Medical Devices
51	全球唯一医疗器械标识数据库（GUDID）	Global Unique Device  Identification Database (GUDID)
52	全球唯一医疗器械标识数据库（GUDID）：2015年9月24日数据提交合规日期	Global Unique Device  Identification Database (GUDID) Data Submission Compliance Date of September  24, 2015
53	良好进口商规范	Good Importer Practices
54	关于已获批准的药品和已获批准或许可的医疗器械的未经批准的新用途的医学期刊论文学或科学参考出版物分销的良好重印规范	Good Reprint Practices for the  Distribution of Medical Journal Articles and Medical or Scientific Reference  Publications on Unapproved New
55	制造方法或工艺变更的30天通知、135天上市前批准（PMA）补充申请和75天人道主义器械豁免（HDE）补充申请	30-Day Notices, 135-Day  Premarket Approval (PMA) Supplements and 75-Day Humanitarian Device Exemption  (HDE) Supplements for Manufacturing Method or Process Changes
56	共识标准的认可和使用	Recognition and Use of Consensus  Standards
57	单个提交中多种器械或多种适应症的捆绑	Bundling Multiple Devices or  Multiple Indications in a Single Submission
58	传统和简易510（k）的格式	Format for traditional and  Abbreviated 510(k)s
59	FDA和行业关于上市前通知（510（k））提交的行动：对FDA审查时间和目标的影响	FDA and Industry Actions on  Premarket Notification (510(k)) Submissions Effect on FDA Review Clock and  Goals
60	上市前通知提交（510（k））用户费用及退款	User Fees and Refunds for  Premarket Notification Submissions (510(k)s)
61	513（g）信息请求的用户费	Guidance for Industry and Food  and Drug Administration Staff - User Fees for 513(g) Requests for Information
62	实质等同性决定中标准的使用	Use of Standards in Substantial  Equivalence Determinations
63	关于新510(k)范例的常见问题	FREQUENTLY ASKED QUESTIONS ON  THE NEW 510(k) PARADIGM
64	一般特殊预期使用	General Specific Intended Use
65	第三方及FDA工作人员指南；上市前通知第三方审核	Guidance for Third Parties and  FDA Staff; Third Party Review of Premarket Notifications
66	FDA在2000年日期问题方面对医疗器械制造商的要求指南	Guidance on FDA's Expectations  of Medical Device Manufacturers Concerning the Year 2000 Date Problem.pdf
67	医疗器械患者标签指南	Guidance on Medical Device  Patient Labeling
68	关于向用于单次使用器械进行预期由原始制造商进行的再加工的医院报告的不良事件指南	Guidance on Adverse Event  Reporting for Hospitals that Reprocess Devices Intended by the Original  Equipment Manufacturer for Single Use
69	如何准备认证用预申请（Pre-RFD）行业指南草稿	How to Prepare a Pre-Request for  Designation (Pre-RFD) Draft Guidance for Industry.pdf
70	如何准备认证申请（RFD）	How to Write a Request for  Designation (RFD)
71	与器械标签相关的人为因素原则	HUMAN FACTORS PRINCIPLES FOR  MEDICAL DEVICE LABELING
72	适应症声明	Indications for Use  Statement.pdf
73	豁免某些未分类、II类和I类保留医疗器械上市前通知要求的意图	Intent to Exempt Certain  Unclassified, Class II, and Class I Reserved Medical Devices from Premarket  Notification Requirements.pdf
74	联邦食品、药品和化妆品法案第201（h）条器械定义中术语"化学作用"的解释-指南草案	Interpretation of the  Term"Chemical Action" in the Definition of Device under Section  201(h) of the Federal Food, Drug, and Cosmetic Act DRAFT GUIDANCE This  guid.pdf
75	标签医疗器械监管要求	Labeling Regulatory Requirements  for Medical Devices
76	电子防盗系统的标签	Labeling for Electronic  Anti-Theft Systems
77	利用现有临床数据推断医疗器械的儿科用途	Leveraging Existing Clinical  Data for Extrapolation to Pediatric Uses of Medical Devices
78	人为因素审核最高优先级器械清单	List of Highest Priority Devices  for Human Factors Review
79	制造地点变更补充材料：内容与提交	Manufacturing Site Change  Supplements Content and Submission
80	第III部分 – 科学和技术信息指南	PART III- GUIDANCE ON SCIENTIFIC  AND TECHNICAL INFORMATION
81	医疗器械附件——描述配件及新配件类型的分类途径	Medical Device  Accessories–Describing Accessories and Classification Pathway for New  Accessory Types
82	医疗器械分类产品代码	Medical Device Classification  Product Codes
83	医疗器械开发工具	Medical Device Development Tools
84	制造商的医疗器械报告	Medical Device Reporting for  Manufacturers
85	使用机构的医疗器械报告	Medical Device Reporting for  User Facilities
86	医疗器械追踪	Medical Device tracking
87	医疗器械上市后的网络安全管理	Postmarket Management of  Cybersecurity in Medical Devices
88	《联邦食品、药品和化妆品法案》第552节下的上市后监督	Postmarket Surveillance Under  Section 522 of the Federal Food, Drug, and Cosmetic Act
89	510（k）拒绝接受政策	Refuse to Accept Policy for  510(k)s
90	医疗器械申报材料中关于计算建模研究的报告	Reporting of Computational  Modeling Studies in Medical Device Submissions
91	关于现有型号系列中新型号的报告	Reporting of New Model Numbers  to Existing Model families
92	510（k）计划：在上市前通知[510（k）]中评价实质等同性	The 510(k) Program Evaluating  Substantial Equivalence in Premarket Notifications [510(k)]-Guidance for  Industry and Food and Drug Administration Staff
93	良好实验室管理实践在器械上市前认证中的适用性：问答	The Applicability of Good  Laboratory Practice in Premarket Device Submissions Questions & Answers
94	新510（K）-在上市前通知中证明实质等同性的替代方法	The New 510(k)  Paradigm-Alternate Approaches to Demonstrating Substantial Equivalence in  Premarket Notifications
95	毒理学风险评估委员会＃G89-1（蓝皮书备忘录）（纯文本）	Toxicology Risk Assessment  Committee #G89-1 (blue book memo) (Text Only)
96	上市前通知（510（k））认证的传递-问答	transfer of a Premarket  Notification (510(k)) Clearance – Questions and Answers-Draft Guidance for  Industry and Food and Drug Administration Staff
97	唯一器械标识系统：唯一器械标识符(UDI)的形式和内容	Unique Device Identification  System:Form and Content of the Unique Device Identifier (UDI)
98	唯一医疗器械标识系统：小型企业合规指南	Unique Device Identification  System:Small Entity Compliance Guide
99	唯一器械标识:器械直接标记	Unique Device Identification:  Direct Marking of Devices
100	唯一器械标识号系统 常见问题, 第1卷	Unique Device Identifier System  Frequently Asked Questions, Vol. 1
101	使用真实应用证据来支持对医疗器械作出监管决策	Use of Real-World Evidence to  Support Regulatory Decision-Making for Medical DevicesAdministration Staff
102	使用说明中危险警告的翻版	Reproduction of Hazard Warnings  in User Instructions
103	与制造商报告编号格式的差异 – 编号5	Variance from Manufacturer  Report Number Format - No. 5
104	医疗器械中的射频无线技术	Radio Frequency  Wireless Technology in Medical Devices
105	医学影像管理器械上市前通告申报指南	Guidance for the  Submission Of Premarket Notifications for Medical Image Management Devices
106	关于"包含现成（OTS）软件的网络化医疗器械的网络安全"行业指南的医疗机构用信息	Information for  Healthcare Organizations about FDA's Guidance for Industry Cybersecurity for  Networked Medical Devices Containing Off-The-Shelf (OTS) Software
107	支持电动医疗器械电磁兼容性（EMC）声明的资料	Information  to Support a Claim of Electromagnetic Compatibility (EMC) of  Electrically-Powered Medical Devices
108	卫生和公众服务部 - 灯具兼容性政策	DEPARTMENT  OF HEALTH & HUMAN SERVICES - POLICY ON LAMP COMPATIBILITY
109	医疗激光产品使用说明	User  Instructions for Medical LASER Products
110	合格评定认可计划 (ASCA) 试点计划	The  Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program
111	医疗器械提交的反馈请求和会议：Q-提交计划	Requests  for Feedback and Meetings for Medical Device Submissions: The Q-Submission  Program
112	医疗器械的电磁兼容性 (EMC)	Electromagnetic  Compatibility (EMC) of Medical Devices

Zzzno8

谢谢分享      

kekeaisky

谢谢分享  

余默

谢谢分享

ye123

感谢分享！

dajiating

谢谢分享   

Nelkart

谢谢谢谢            

王偉仲

非常实用，感谢无私分享~!

王偉仲

Battery Guidelines 请问有具体网址吗? 目前下载不到这份档案。

王偉仲

Guidance On the Content Of &#160remarket Notification [510(K)] Submissions for Protective Restraints =>请问这份还有连结吗?

卷卷12

谢谢楼主分享

背包客的路

谢谢分享，收集备用

纵横江湖的小蟹

谢谢楼主的分享

peggyzt

谢谢分享，非常感谢