| 1 | 人工智能驱动设备软件功能的预定变更控制计划的市场提交建议：行业和食品药品管理局工作人员的指导 | Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence-Enabled Device Software Functions: Guidance for Industry and Food and Drug Administration Staff | PDF (678.22 KB) | Premarket, Biologics, Drugs, Medical Devices, Digital Health | Final | 12/04/2024 | |
| 2 | 骨科非脊柱骨板、螺钉和垫圈 - 市场前通知（510(k)）提交：行业和食品药品监督管理局工作人员指南 | Orthopedic Non-Spinal Bone Plates, Screws, and Washers - Premarket Notification (510(k)) Submissions: Guidance for Industry and Food and Drug Administration Staff | PDF (766.28 KB) | Premarket, 510(k), Medical Devices, Orthopedic | Final | 11/22/2024 | |
| 3 | 510(k) 第三方审查程序和第三方紧急使用授权（EUA）审查：行业、食品和药物管理局工作人员及第三方审查组织的指导 | 510(k) Third Party Review Program and Third Party Emergency Use Authorization (EUA) Review: Guidance for Industry, Food and Drug Administration Staff, and Third Party Review Organizations | PDF (608.67 KB) | Premarket, 510(k), Administrative / Procedural, Medical Devices | Final | 11/21/2024 | |
| 4 | 牙科骨内植入体和牙科骨内植入体基台 - 基于安全和性能的途径的性能标准：行业和食品药品监督管理局工作人员指南 | Endosseous Dental Implants and Endosseous Dental Implant Abutments - Performance Criteria for Safety and Performance Based Pathway: Guidance for Industry and Food and Drug Administration Staff | PDF (490.46 KB) | Premarket, 510(k), Dental , Medical Devices | Final | 10/15/2024 | |
| 5 | 牙科水门汀 - 基于安全和性能的途径的性能标准：行业和食品药品监督管理局工作人员指南 | Dental Cements - Performance Criteria for Safety and Performance Based Pathway: Guidance for Industry and Food and Drug Administration Staff | PDF (528.42 KB) | Premarket, 510(k), Dental , Medical Devices | Final | 09/30/2024 | |
| 6 | 基于安全和性能的途径的牙科印模材料 - 性能标准:针对工业界和食品药品管理局工作人员的指导 | Dental Impression Materials - Performance Criteria for Safety and Performance Based Pathway: Guidance for Industry and Food and Drug Administration Staff | PDF (473.92 KB) | Premarket, 510(k), Dental , Medical Devices | Final | 09/30/2024 | |
| 7 | 医疗电气设备、医疗电气系统和实验室医疗设备的基本安全性和基本性能 - 合格评定认可计划（ASCA）的标准具体信息：行业、认可机构、测试实验室和食品药品监督管理局工作人员指南草案 | Basic Safety and Essential Performance of Medical Electrical Equipment, Medical Electrical Systems, and Laboratory Medical Equipment - Standards Specific Information for the Accreditation Scheme for Conformity Assessment (ASCA) Program: Draft Guidance for Industry, Accreditation Bodies, Testing Laboratories, and Food and Drug Administration Staff | PDF (657.84 KB) | Premarket, Biologics, Medical Devices | Draft | 09/23/2024 | |
| 8 | 符合性评估认可计划(ASCA)项目:面向工业、认可机构、检测实验室以及食品药品管理局工作人员的指导草案 | The Accreditation Scheme for Conformity Assessment (ASCA) Program: Draft Guidance for Industry, Accreditation Bodies, Testing Laboratories, and Food and Drug Administration Staff | PDF (1.42 MB) | Premarket, Biologics, Medical Devices | Draft | 09/23/2024 | |
| 9 | 乳腺摄影设施针对不利认证决定、证书暂停/撤销或患者及转诊提供者通知命令的上诉选项：乳腺摄影设施和食品药品监督管理局工作人员的指导 | Appeal Options Available to Mammography Facilities Concerning Adverse Accreditation Decisions, Suspension/Revocation of Certificates, or Patient and Referring Provider Notification Orders: Guidance for Mammography Facilities and Food and Drug Administration Staff | PDF (335.19 KB) | Investigation & Enforcement, Administrative / Procedural, Medical Devices, Radiation-Emitting Products, Radiological Health, Radiology | Final | 09/10/2024 | |
| 10 | 制造商自愿故障汇总报告(VMSR)计划:面向行业和食品药品管理局工作人员的指南 | Voluntary Malfunction Summary Reporting (VMSR) Program for Manufacturers: Guidance for Industry and Food and Drug Administration Staff | PDF (795.35 KB) | Biologics, Medical Devices | Final | 08/29/2024 | |
| 11 | 医疗器械新申请电子提交模板：行业和食品药品监督管理局工作人员指南 | Electronic Submission Template for Medical Device De Novo Requests: Guidance for Industry and Food and Drug Administration Staff | PDF (664.24 KB) | Premarket, Electronic Submissions, Biologics, Medical Devices | Final | 08/23/2024 | |
| 12 | 预定的医疗器械变更控制计划：行业和FDA工作人员的草案指导 | Predetermined Change Control Plans for Medical Devices: Draft Guidance for Industry and FDA Staff | PDF (1.39 MB) | Premarket, Medical Devices | Draft | 08/22/2024 | |
| 13 | 牙科复合树脂设备 - 市场前通知（510(k)）提交：行业和食品药品监督管理局工作人员的草案指南 | Dental Composite Resin Devices - Premarket Notification (510(k)) Submissions: Draft Guidance for Industry and Food and Drug Administration Staff | PDF (532.96 KB) | Premarket, 510(k), Dental , Medical Devices | Draft | 07/12/2024 | |
| 14 | 针对治疗阿片类药物使用障碍的设备研究的临床考虑：针对行业和食品药品监督管理局工作人员的指导 | Clinical Considerations for Studies of Devices Intended to Treat Opioid Use Disorder: Guidance for Industry and Food and Drug Administration Staff | PDF (538.76 KB) | Medical Devices | Final | 07/11/2024 | |
| 15 | 药物和生物制品输送设备的基本药物输送输出：行业草案指导 | Essential Drug Delivery Outputs for Devices Intended to Deliver Drugs and Biological Products: Draft Guidance for Industry | PDF (552.4 KB) | Biologics, Drugs, Medical Devices, Combination Products, Pediatric Product Development | Draft | 06/28/2024 | |
| 16 | 实验室开发的测试：小型实体合规指南：针对实验室制造商和食品药品监督管理局工作人员的指导 | Laboratory Developed Tests: Small Entity Compliance Guide: Guidance for Laboratory Manufacturers and Food and Drug Administration Staff | PDF (700.68 KB) | Biologics, Medical Devices, IVDs (In Vitro Diagnostic Devices) | Final | 06/25/2024 | |
| 17 | 适用于生物研究监测检查的流程和实践：行业草案指南 | Processes and Practices Applicable to Bioresearch Monitoring Inspections: Draft Guidance for Industry | PDF (516.52 KB) | Clinical Trials, Compliance, Postmarket, Premarket, Investigation & Enforcement, Inspection, International, Administrative / Procedural, Animal & Veterinary, Biologics, Dietary Supplements, Drugs, Food & Beverages, Medical Devices, Radiation-Emitting Products, Tobacco, Bioequivalence, Biopharmaceutics, Biosimilars, Investigational New Drug Application (INDA), Food & Color Additives, Generic Drugs, HUD/HDE, Investigational Device Exemption (IDE), Premarket Approval (PMA), IVDs (In Vitro Diagnostic Devices), Investigational New Animal Drug (INAD), New Animal Drug Application (NADA), Vaccines | Draft | 06/05/2024 | |
| 18 | 在第564条声明的紧急情况下对测试的执行政策的考虑：针对行业和食品药品监督管理局工作人员的草案指导 | Consideration of Enforcement Policies for Tests During a Section 564 Declared Emergency: Draft Guidance for Industry and Food and Drug Administration Staff | PDF (422.3 KB) | Outbreak, IVDs (In Vitro Diagnostic Devices), Medical Devices | Draft | 05/06/2024 | |
| 19 | 动物研究用于牙科骨移植材料设备 - 市场前通知（510(k)）提交：行业和食品药品监督管理局工作人员的草案指南 | Animal Studies for Dental Bone Grafting Material Devices - Premarket Notification (510(k)) Submissions: Draft Guidance for Industry and Food and Drug Administration Staff | PDF (686.61 KB) | Premarket, 510(k), Dental , Medical Devices | Draft | 03/29/2024 | |
| 20 | 医疗器械提交的反馈和会议请求：Q-提交计划 - 行业和食品药品监督管理局工作人员的草案指导 | Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program - Draft Guidance for Industry and Food and Drug Administration Staff | PDF (1.07 MB) | Premarket, Administrative / Procedural, Biologics, Medical Devices | Draft | 03/15/2024 | |
| 21 | 选择医疗器械用户费用小企业资格和认证指南的更新：行业和食品药品监督管理局工作人员的草案指南 | Select Updates for the Medical Device User Fee Small Business Qualification and Certification Guidance: Draft Guidance for Industry and Food and Drug Administration Staff | PDF (547.72 KB) | User Fees, Medical Devices, Radiation-Emitting Products | Draft | 02/22/2024 | |
| 22 | 在标记为无菌的设备的上市前通知（510(k)）提交中无菌信息的提交和审查：针对行业和食品药品监督管理局工作人员的指导 | Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile: Guidance for Industry and Food and Drug Administration Staff | PDF (273.01 KB) | Premarket, 510(k), Medical Devices | Final | 01/08/2024 | |
| 23 | 评估医疗器械提交中计算建模和仿真的可信度：行业和食品药品监督管理局工作人员的指导 | Assessing the Credibility of Computational Modeling and Simulation in Medical Device Submissions: Guidance for Industry and Food and Drug Administration Staff | PDF (1.3 MB) | Premarket, Digital Health, Medical Devices | Final | 11/17/2023 | |
| 24 | 选择506J指导的更新：506J设备清单和其他通知：行业和食品药品管理局工作人员的草案指导 | Select Updates for the 506J Guidance: 506J Device List and Additional Notifications: Draft Guidance for Industry and Food and Drug Administration Staff | PDF (392.26 KB) | Postmarket, Medical Devices | Draft | 11/17/2023 | |
| 25 | 请求审查FDA不发放某些设备出口证书决定的流程：行业和食品药品管理局工作人员的指导 | Process to Request a Review of FDA's Decision Not to Issue Certain Export Certificates for Devices: Guidance for Industry and Food and Drug Administration Staff | PDF (494.44 KB) | Postmarket, Export, Import, Medical Devices | Final | 11/03/2023 | |
| 26 | 非侵入性远程监测设备用于支持患者监测的执法政策：行业和食品药品监督管理局工作人员的指导 | Enforcement Policy for Non-Invasive Remote Monitoring Devices Used to Support Patient Monitoring: Guidance for Industry and Food and Drug Administration Staff | PDF (562.96 KB) | Premarket, 510(k), Labeling, Medical Devices | Final | 10/19/2023 | |
| 27 | 在磁共振（MR）环境中对医疗设备进行安全测试和标记：行业和食品药品监督管理局工作人员的指导 | Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment: Guidance for Industry and Food and Drug Administration Staff | PDF (1.02 MB) | Premarket, Labeling, Safety - Issues, Errors, and Problems, Medical Devices, Radiation-Emitting Products | Final | 10/10/2023 | |
| 28 | 抗微生物敏感性测试（AST）系统设备 - 更新设备标签中的临界值：行业和食品药品监督管理局工作人员的指导 | Antimicrobial Susceptibility Test (AST) System Devices – Updating Breakpoints in Device Labeling: Guidance for Industry and Food and Drug Administration Staff | PDF (340.66 KB) | Antimicrobial Resistance, Medical Devices | Final | 09/29/2023 | |
| 29 | 医疗设备中的网络安全：质量体系考虑和上市前提交内容：行业和食品药品管理局工作人员的指导 | Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions: Guidance for Industry and Food and Drug Administration Staff | PDF (674.46 KB) | Premarket, Digital Health, Medical Devices | Final | 09/27/2023 | |
| 30 | 与减重相关的医疗器械 - 临床研究和利益风险考虑：行业和食品药品监督管理局工作人员的草案指导 | Medical Devices with Indications Associated with Weight Loss - Clinical Study and Benefit-Risk Considerations: Draft Guidance for Industry and Food and Drug Administration Staff | PDF (1.37 MB) | Premarket, Gastroenterology-Urology , Medical Devices | Draft | 09/15/2023 | |
| 31 | 突破性设备计划：行业和食品药品管理局工作人员指南 | Breakthrough Devices Program: Guidance for Industry and Food and Drug Administration Staff | PDF (839.14 KB) | Biologics, Medical Devices | Final | 09/14/2023 | |
| 32 | 人因工程原则在组合产品中的应用：问题与答案：行业和FDA工作人员的指导 | Application of Human Factors Engineering Principles for Combination Products: Questions and Answers: Guidance for Industry and FDA Staff | PDF (337.28 KB) | Biologics, Drugs, Medical Devices, Combination Products | Final | 09/07/2023 | |
| 33 | 510(k)植入设备的证据期望：针对行业和食品药品监督管理局工作人员的草案指导 | Evidentiary Expectations for 510(k) Implant Devices: Draft Guidance for Industry and Food and Drug Administration Staff | PDF (815.33 KB) | Premarket, 510(k), Biologics, Medical Devices | Draft | 09/07/2023 | |
| 34 | 在冠状病毒病（COVID-19）公共卫生紧急状态期间的口罩和防护面罩的执行政策：针对行业和食品药品监督管理局工作人员的指导 | Enforcement Policy for Face Masks and Barrier Face Coverings During the Coronavirus Disease (COVID-19) Public Health Emergency : Guidance for Industry and Food and Drug Administration Staff | PDF (527.83 KB) | Premarket, Labeling, Medical Devices | Final | 09/05/2023 | |
| 35 | 医疗设备中现成软件的使用：行业和食品药品监督管理局工作人员的指导 | Off-The-Shelf Software Use in Medical Devices: Guidance for Industry and Food and Drug Administration Staff | PDF (524.43 KB) | Premarket, Digital Health, Medical Devices | Final | 08/11/2023 | |
| 36 | 医疗器械开发工具的资格：针对行业、工具开发者和食品药品监督管理局工作人员的指导 | Qualification of Medical Device Development Tools: Guidance for Industry, Tool Developers, and Food and Drug Administration Staff | PDF (386.33 KB) | Premarket, Administrative / Procedural, Digital Health, Medical Devices | Final | 07/17/2023 | |
| 37 | 医疗器械软件功能的上市前提交内容：行业和食品药品监督管理局工作人员的指导 | Content of Premarket Submissions for Device Software Functions: Guidance for Industry and Food and Drug Administration Staff | PDF (1.2 MB) | Premarket, Biologics, Drugs, Medical Devices, Digital Health | Final | 06/14/2023 | |
| 38 | 非临床性能评估在电动切割手术中使用的组织容纳系统：针对行业和食品药品监督管理局工作人员的指导 | Non-Clinical Performance Assessment of Tissue Containment Systems Used During Power Morcellation Procedures: Guidance for Industry and Food and Drug Administration Staff | PDF (362.84 KB) | Premarket, Clinical - Medical, General & Plastic Surgery , Obstetrical & Gynecological, Medical Devices | Final | 05/26/2023 | |
| 39 | 基于风险的临床研究监测问答：行业指导 | A Risk-Based Approach to Monitoring of Clinical Investigations Questions and Answers: Guidance for Industry | PDF (265.71 KB) | Administrative / Procedural, Biologics, Drugs, Medical Devices | Final | 04/12/2023 | |
| 40 | 软性（亲水性）日常佩戴隐形眼镜 - 安全和性能基础路径的性能标准：行业和食品药品监督管理局工作人员的指导 | Soft (Hydrophilic) Daily Wear Contact Lenses - Performance Criteria for Safety and Performance Based Pathway: Guidance for Industry and Food and Drug Administration Staff | PDF (565.55 KB) | Premarket, 510(k), Medical Devices, Ophthalmic | Final | 03/28/2023 | |
| 41 | 在2019冠状病毒病（COVID-19）公共卫生紧急状态期间发布的执法政策下，医疗设备的过渡计划：针对行业、其他利益相关者和食品药品监督管理局工作人员的指导 | Transition Plan for Medical Devices That Fall Within Enforcement Policies Issued During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency: Guidance for Industry, Other Stakeholders, and Food and Drug Administration Staff | PDF (528.07 KB) | Premarket, Postmarket, Medical Devices | Final | 03/27/2023 | |
| 42 | 诊断X射线系统及其主要组件的性能标准（21CFR 1020.30, 1020.31, 1020.32, 1020.33）；小型实体合规指南 | Performance Standard for Diagnostic X-Ray Systems and Their Major Components (21CFR 1020.30, 1020.31, 1020.32, 1020.33); Small Entity Compliance Guide | PDF (371.39 KB) | Medical Devices, Radiation-Emitting Products, Radiology | Final | 02/22/2023 | |
| 43 | 诊断超声系统和传感器的市场准入：行业和食品药品监督管理局工作人员的指导 | Marketing Clearance of Diagnostic Ultrasound Systems and Transducers : Guidance for Industry and Food and Drug Administration Staff | PDF (898.34 KB) | Premarket, 510(k), Medical Devices, Radiation-Emitting Products, Radiological Health, Radiology | Final | 02/21/2023 | |
| 44 | 超声波热疗设备的政策澄清和上市前通知 [510(k)] 提交：行业和食品药品监督管理局工作人员的指导 | Policy Clarification and Premarket Notification [510(k)] Submissions for Ultrasonic Diathermy Devices: Guidance for Industry and Food and Drug Administration Staff | PDF (545.39 KB) | Premarket, 510(k), Medical Devices, Physical Medicine | Final | 02/21/2023 | |
| 45 | 2019冠状病毒病检测政策（修订版）：开发者和食品药品监督管理局工作人员的指导 | Policy for Coronavirus Disease-2019 Tests (Revised): Guidance for Developers and Food and Drug Administration Staff | PDF (372.44 KB) | Premarket, CLIA (Clinical Laboratory Improvement Amendments), Immunology & Microbiology , IVDs (In Vitro Diagnostic Devices), Medical Devices | Final | 01/12/2023 | |
| 46 | 医疗器械市场提交中的人因信息内容：行业和食品药品监督管理局工作人员的草案指导 | Content of Human Factors Information in Medical Device Marketing Submissions: Draft Guidance for Industry and Food and Drug Administration Staff | PDF (916.09 KB) | Medical Devices | Draft | 12/09/2022 | |
| 47 | 根据最少负担条款制定和应对缺陷：行业和食品药品管理局工作人员指南 | Developing and Responding to Deficiencies in Accordance with the Least Burdensome Provisions: Guidance for Industry and Food and Drug Administration Staff | PDF (426.19 KB) | Premarket, Medical Devices, Premarket Approval (PMA) | Final | 10/26/2022 | |
| 48 | PMA命令下后批准研究处理程序：行业和食品药品管理局工作人员的指导 | Procedures for Handling Post-Approval Studies Imposed by PMA Order: Guidance for Industry and Food and Drug Administration Staff | PDF (438.61 KB) | Medical Devices | Final | 10/07/2022 | |
| 49 | 用户费用和预市场批准申请及设备生物制品许可证申请的退款：行业和食品药品监督管理局工作人员的指导 | User Fees and Refunds for Premarket Approval Applications and Device Biologics License Applications: Guidance for Industry and Food and Drug Administration Staff | PDF (417.84 KB) | Premarket, User Fees, Biologics, Medical Devices | Final | 10/05/2022 | |
| 50 | 用户费用用于513(g)信息请求：行业和食品药品管理局工作人员的指导 | User Fees for 513(g) Requests for Information: Guidance for Industry and Food and Drug Administration Staff | PDF (322.37 KB) | Premarket, User Fees, Biologics, Medical Devices | Final | 10/05/2022 | |
| 51 | FDA和行业在上市前批准申请（PMA）上的行动：对FDA审查时限和目标的影响：行业和食品药品管理局工作人员的指导 | FDA and Industry Actions on Premarket Approval Applications (PMAs): Effect on FDA Review Clock and Goals: Guidance for Industry and Food and Drug Administration Staff | PDF (471.95 KB) | Premarket, Biologics, Medical Devices, Premarket Approval (PMA) | Final | 10/03/2022 | |
| 52 | 计算机辅助检测设备在放射学图像和放射学设备数据中的应用 - 市场前通知 [510(k)] 提交：行业和食品药品监督管理局工作人员的指导 | Computer-Assisted Detection Devices Applied to Radiology Images and Radiology Device Data - Premarket Notification [510(k)] Submissions: Guidance for Industry and Food and Drug Administration Staff | PDF (589.83 KB) | Premarket, Medical Devices, Radiation-Emitting Products, Radiology | Final | 09/29/2022 | |
| 53 | 临床性能评估：针对应用于放射影像和放射设备数据的计算机辅助检测设备在上市前通知（510(k)）提交中的考虑：行业和FDA工作人员的指导 | Clinical Performance Assessment: Considerations for Computer-Assisted Detection Devices Applied to Radiology Images and Radiology Device Data in Premarket Notification (510(k)) Submissions: Guidance for Industry and FDA Staff | PDF (499.67 KB) | Premarket, 510(k), Digital Health, Radiology, Labeling, Medical Devices, Radiation-Emitting Products | Final | 09/28/2022 | |
| 54 | 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：行业和食品药品监督管理局工作人员的指导 | Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communications Devices: Guidance for Industry and Food and Drug Administration Staff | PDF (371.78 KB) | Biologics, Medical Devices, Digital Health | Final | 09/28/2022 | |
| 55 | 涉及儿童的医疗产品临床研究的伦理考虑：行业、赞助商和伦理审查委员会的草案指导 | Ethical Considerations for Clinical Investigations of Medical Products Involving Children: Draft Guidance for Industry, Sponsors, and IRBs | PDF (433.98 KB) | Biologics, Drugs, Medical Devices, Clinical - Medical, Pediatric Product Development | Draft | 09/26/2022 | |
| 56 | 猴痘检测政策以应对公共卫生紧急情况：实验室、商业制造商和食品药品监督管理局工作人员的指导 | Policy for Monkeypox Tests to Address the Public Health Emergency: Guidance for Laboratories, Commercial Manufacturers and Food and Drug Administration Staff | PDF (599.02 KB) | Medical Devices | Final | 09/07/2022 | |
| 57 | 体外诊断设备替代试剂和仪器系列政策：行业和FDA工作人员指南 | Replacement Reagent and Instrument Family Policy for In Vitro Diagnostic Devices: Guidance for Industry and FDA Staff | PDF (930.94 KB) | Laboratory Tests, Medical Devices | Final | 08/17/2022 | |
| 58 | 唯一设备识别：关于I类和未分类设备的合规日期、直接标记以及某些设备的全球唯一设备识别数据库要求的政策：行业和食品药品监督管理局工作人员的指导 | Unique Device Identification: Policy Regarding Compliance Dates for Class I and Unclassified Devices, Direct Marking, and Global Unique Device Identification Database Requirements for Certain Devices: Guidance for Industry and Food and Drug Administration Staff | PDF (558.76 KB) | Biologics, Medical Devices, Labeling, UDI | Final | 07/25/2022 | |
| 59 | 医疗设备的电磁兼容性（EMC）：行业和食品药品监督管理局工作人员的指导 | Electromagnetic Compatibility (EMC) of Medical Devices: Guidance for Industry and Food and Drug Administration Staff | PDF (532.25 KB) | Biologics, Medical Devices, Radiation-Emitting Products, Investigational Device Exemption (IDE), Radiological Health, Radiology, Safety - Issues, Errors, and Problems | Final | 06/06/2022 | |
| 60 | 拒绝接受510(k)政策：行业和食品药品监督管理局工作人员指南 | Refuse to Accept Policy for 510(k)s: Guidance for Industry and Food and Drug Administration Staff | PDF (1.41 MB) | Premarket, 510(k), Administrative / Procedural, Biologics, Medical Devices | Final | 04/21/2022 | |
| 61 | 面部螺钉系统 - 安全和性能基础路径的性能标准：行业和食品药品监督管理局工作人员的指导 | Facet Screw Systems - Performance Criteria for Safety and Performance Based Pathway: Guidance for Industry and Food and Drug Administration Staff | PDF (618.36 KB) | Premarket, 510(k), Medical Devices | Final | 04/13/2022 | |
| 62 | 外科缝合线 - 安全和性能基础路径的性能标准：行业和食品药品监督管理局工作人员的指导 | Surgical Sutures - Performance Criteria for Safety and Performance Based Pathway: Guidance for Industry and Food and Drug Administration Staff | PDF (395.53 KB) | Premarket, 510(k), Medical Devices | Final | 04/11/2022 | |
| 63 | 医疗器械和放射健康中心（CDRH）上诉程序：行业和食品药品监督管理局工作人员指南 | Center for Devices and Radiological Health (CDRH) Appeals Processes: Guidance for Industry and Food and Drug Administration Staff | PDF (657.39 KB) | Administrative / Procedural, Medical Devices | Final | 03/02/2022 | |
| 64 | 选择、开发、修改和调整患者报告结果工具用于医疗器械评估的原则：针对行业、食品和药物管理局工作人员及其他利益相关者的指导 | Principles for Selecting, Developing, Modifying, and Adapting Patient-Reported Outcome Instruments for Use in Medical Device Evaluation: Guidance for Industry and Food and Drug Administration Staff, And Other Stakeholders | PDF (436.61 KB) | Premarket, Postmarket, Biologics, Medical Devices | Final | 01/26/2022 | |
| 65 | 良性前列腺增生（BPH）治疗设备的非临床和临床研究：行业和食品药品监督管理局工作人员的指导 | Non-Clinical and Clinical Investigation of Devices Used for the Treatment of Benign Prostatic Hyperplasia (BPH): Guidance for Industry and Food and Drug Administration Staff | PDF (559.79 KB) | Premarket, Gastroenterology-Urology , Good Clinical Practice (GCP), Medical Devices | Final | 12/27/2021 | |
| 66 | 关节镜泵管道套件用于多位患者的使用 - 市场前通知（510(k)）提交：行业和食品药品管理局工作人员的指导 | Arthroscopy Pump Tubing Sets Intended for Multiple Patient Use - Premarket Notification (510(k)) Submissions: Guidance for Industry and Food and Drug Administration Staff | PDF (488.26 KB) | Premarket, 510(k), Medical Devices, Orthopedic | Final | 12/23/2021 | |
| 67 | 对新分类请求的接受审查：行业和食品药品管理局工作人员的指导 | Acceptance Review for De Novo Classification Requests: Guidance for Industry and Food and Drug Administration Staff | PDF (893.39 KB) | Premarket, Biologics, Medical Devices | Final | 10/05/2021 | |
| 68 | 调查员责任 - 研究药物和设备的安全报告：行业草案指导 | Investigator Responsibilities – Safety Reporting for Investigational Drugs and Devices: Draft Guidance for Industry | PDF (117.55 KB) | Biologics, Drugs, Medical Devices, Device & Drug Safety | Draft | 09/29/2021 | |
| 69 | 医疗器械中含有镍钛合金的非临床评估的技术考虑：行业和食品药品监督管理局工作人员的指导 | Technical Considerations for Non-Clinical Assessment of Medical Devices Containing Nitinol: Guidance for Industry and Food and Drug Administration Staff | PDF (560.51 KB) | Premarket, Animal & Veterinary, Medical Devices, Animal Cell-Based Products | Final | 07/09/2021 | |
| 70 | 经肠道喂养管给药的口服药物产品：体外测试和标签建议：行业草案指导 | Oral Drug Products Administered Via Enteral Feeding Tube: In Vitro Testing and Labeling Recommendations: Draft Guidance for Industry | PDF (180.48 KB) | Chemistry, Manufacturing, and Controls (CMC), Labeling, Drugs, Medical Devices, Pharmaceutical Quality | Draft | 06/02/2021 | |
| 71 | 植入式脑-计算机接口（BCI）设备用于瘫痪或截肢患者 - 非临床测试和临床考虑：行业和食品药品监督管理局工作人员的指导 | Implanted Brain-Computer Interface (BCI) Devices for Patients with Paralysis or Amputation - Non-clinical Testing and Clinical Considerations: Guidance for Industry and Food and Drug Administration Staff | PDF (640.22 KB) | Premarket, Investigational Device Exemption (IDE), Medical Devices, Neurological | Final | 05/20/2021 | |
| 72 | 医疗器械安全技术计划：行业和食品药品监督管理局工作人员指南 | Safer Technologies Program for Medical Devices: Guidance for Industry and Food and Drug Administration Staff | PDF (250.61 KB) | Premarket, 510(k), Premarket Approval (PMA), Medical Devices | Final | 01/06/2021 | |
| 73 | 腹腔镜电动切割器的产品标签：行业和食品药品监督管理局工作人员的指导 | Product Labeling for Laparoscopic Power Morcellators: Guidance for Industry and Food and Drug Administration Staff | PDF (325.39 KB) | Postmarket, Premarket, 510(k), Labeling, Safety - Issues, Errors, and Problems, Medical Devices, Obstetrical & Gynecological, General & Plastic Surgery | Final | 12/30/2020 | |
| 74 | 脊柱固定系统 - 安全和性能基础路径的性能标准：行业和食品药品监督管理局工作人员的指导 | Spinal Plating Systems - Performance Criteria for Safety and Performance Based Pathway: Guidance for Industry and Food and Drug Administration Staff | PDF (463.16 KB) | Premarket, 510(k), Medical Devices, Orthopedic | Final | 12/11/2020 | |
| 75 | 保密证书：对赞助者、赞助研究者、研究人员、行业和食品药品监督管理局工作人员的指导 | Certificates of Confidentiality: Guidance for Sponsors, Sponsor-Investigators, Researchers, Industry, and Food and Drug Administration Staff | PDF (167 KB) | Research, Animal & Veterinary, Biologics, Cosmetics, Dietary Supplements, Drugs, Food & Beverages, Medical Devices, Radiation-Emitting Products, Tobacco, Good Clinical Practice (GCP) | Final | 11/13/2020 | |
| 76 | 检测生物素干扰体外诊断设备：行业指导 | Testing for Biotin Interference in In Vitro Diagnostic Devices: Guidance for Industry | PDF (90.06 KB) | Biologics, Medical Devices, Blood Products, IVDs (In Vitro Diagnostic Devices) | Final | 10/16/2020 | |
| 77 | 乳房植入物 - 改善患者沟通的某些标签建议：行业和食品药品监督管理局工作人员的指导 | Breast Implants - Certain Labeling Recommendations to Improve Patient Communication: Guidance for Industry and Food and Drug Administration Staff | PDF (459.48 KB) | Premarket, General & Plastic Surgery , Labeling, Medical Devices | Final | 09/29/2020 | |
| 78 | 非处方自我监测血糖测试系统：行业和食品药品监督管理局工作人员指南 | Self-Monitoring Blood Glucose Test Systems for Over-the-Counter Use: Guidance for Industry and Food and Drug Administration Staff | PDF (827.21 KB) | Premarket, 510(k), Clinical Chemistry & Clinical Toxicology , Drugs, Medical Devices, Over-the-Counter Drugs | Final | 09/29/2020 | |
| 79 | 医疗器械生物相容性测试 - 符合性评估认证计划（ASCA）试点项目的标准特定信息：针对行业、认证机构、测试实验室和食品药品监督管理局工作人员的指导 | Biocompatibility Testing of Medical Devices - Standards Specific Information for the Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program: Guidance for Industry, Accreditation Bodies, Testing Laboratories, and Food and Drug Administration Staff | PDF (871.63 KB) | Premarket, Biologics, Medical Devices | Final | 09/25/2020 | |
| 80 | 自愿共识标准的认可与撤回：行业和食品药品监督管理局工作人员的指导 | Recognition and Withdrawal of Voluntary Consensus Standards: Guidance for Industry and Food and Drug Administration Staff | PDF (559.96 KB) | Administrative / Procedural, Medical Devices | Final | 09/15/2020 | |
| 81 | 常规导尿管 - 安全性和性能基础路径的性能标准：行业和食品药品监督管理局工作人员的指导 | Conventional Foley Catheters - Performance Criteria for Safety and Performance Based Pathway: Guidance for Industry and Food and Drug Administration Staff | PDF (94.14 KB) | Premarket, 510(k), Gastroenterology-Urology , Medical Devices | Final | 08/14/2020 | |
| 82 | 多功能设备产品：政策和考虑：行业和食品药品管理局的指导 | Multiple Function Device Products: Policy and Considerations: Guidance for Industry and Food and Drug Administration | PDF (631.95 KB) | Postmarket, Premarket, Biologics, Drugs, Medical Devices, Combination Products, Digital Health | Final | 07/29/2020 | |
| 83 | 提供医疗器械电子格式的监管提交 - 根据《联邦食品、药品和化妆品法》第745A(b)条的提交：行业和食品药品管理局工作人员的指导 | Providing Regulatory Submissions for Medical Devices in Electronic Format - Submissions Under Section 745A(b) of the Federal Food, Drug, and Cosmetic Act: Guidance for Industry and Food and Drug Administration Staff | PDF (385.46 KB) | Electronic Submissions, Biologics, Medical Devices | Final | 07/15/2020 | |
| 84 | 后颈螺钉系统的分类：小实体合规指南：针对行业和食品药品监督管理局工作人员的指导 | Classification of Posterior Cervical Screw Systems: Small Entity Compliance Guide: Guidance for Industry and Food and Drug Administration Staff | PDF (58.41 KB) | Medical Devices, Orthopedic, Premarket Approval (PMA) | Final | 05/04/2020 | |
| 85 | 在某些FDA对设备机构的检查后非约束性反馈：行业和食品药品管理局工作人员的指导 | Nonbinding Feedback After Certain FDA Inspections of Device Establishments: Guidance for Industry and Food and Drug Administration Staff | PDF (338.73 KB) | Postmarket, Medical Devices | Final | 04/22/2020 | |
| 86 | 开发和标记特定肿瘤治疗产品组的体外伴随诊断设备：行业指南 | Developing and Labeling In vitro Companion Diagnostic Devices for a Specific Group of Oncology Therapeutic Products: Guidance for Industry | PDF (323.18 KB) | Premarket, Biologics, Drugs, Medical Devices, Labeling | Final | 04/13/2020 | |
| 87 | 限制交付系统：口服液体药物产品的流量限制器行业指南 | Restricted Delivery Systems: Flow Restrictors for Oral Liquid Drug Products Guidance for Industry | PDF (143.43 KB) | Biologics, Drugs, Medical Devices, Device & Drug Safety | Draft | 03/17/2020 | |
| 88 | 骨锚 - 市场前通知（510(k)）提交：行业和食品药品管理局工作人员指南 | Bone Anchors - Premarket Notification (510(k)) Submissions: Guidance for Industry and Food and Drug Administration Staff | PDF (503.42 KB) | Premarket, 510(k), Medical Devices, Orthopedic | Final | 03/03/2020 | |
| 89 | 1988年临床实验室改进修正案（CLIA）豁免申请的建议：针对体外诊断设备制造商的行业和食品药品监督管理局工作人员的指导 | Recommendations for Clinical Laboratory Improvement Amendments of 1988 (CLIA) Waiver Applications for Manufacturers of In Vitro Diagnostic Devices: Guidance for Industry and Food and Drug Administration Staff | PDF (596.03 KB) | Biologics, Medical Devices, CLIA (Clinical Laboratory Improvement Amendments) | Final | 02/26/2020 | |
| 90 | 非临床基准性能测试信息在上市前提交中的推荐内容和格式：行业和食品药品管理局工作人员指南 | Recommended Content and Format of Non-Clinical Bench Performance Testing Information in Premarket Submissions: Guidance for Industry and Food and Drug Administration Staff | PDF (383.76 KB) | Premarket, Medical Devices | Final | 12/20/2019 | |
| 91 | 30天通知、135天上市前批准（PMA）补充和75天人道设备豁免（HDE）补充的制造方法或工艺变更：行业和FDA工作人员的指导 | 30-Day Notices, 135-Day Premarket Approval (PMA) Supplements and 75-Day Humanitarian Device Exemption (HDE) Supplements for Manufacturing Method or Process Changes: Guidance for Industry and FDA Staff | PDF (215.75 KB) | Premarket, Administrative / Procedural, Biologics, Medical Devices, Device & Drug Safety, HUD/HDE, Premarket Approval (PMA) | Final | 12/16/2019 | |
| 92 | 批准的上市前批准申请（PMA）年度报告：行业和食品药品监督管理局工作人员的指导 | Annual Reports for Approved Premarket Approval Applications (PMA) : Guidance for Industry and Food and Drug Administration Staff | PDF (146.07 KB) | Premarket, Administrative / Procedural, Device & Drug Safety, Medical Devices, Premarket Approval (PMA) | Final | 12/16/2019 | |
| 93 | 冠状动脉、外周和神经血管导丝 - 性能测试和推荐标签：行业和食品药品监督管理局工作人员的指导 | Coronary, Peripheral, and Neurovascular Guidewires - Performance Tests and Recommended Labeling: Guidance for Industry and Food and Drug Administration Staff | PDF (527.16 KB) | Premarket, 510(k), Cardiovascular , Neurological, Medical Devices | Final | 10/10/2019 | |
| 94 | 《21世纪治愈法案》第3060条款导致的现有医疗软件政策变更：行业和食品药品监督管理局工作人员的指导》 | Changes to Existing Medical Software Policies Resulting from Section 3060 of the 21st Century Cures Act: Guidance for Industry and Food and Drug Administration Staff | PDF (660.31 KB) | Postmarket, Premarket, Biologics, Medical Devices, Digital Health | Final | 09/27/2019 | |
| 95 | 安全与性能基础路径：行业与食品药品管理局的指导 | Safety and Performance Based Pathway: Guidance for Industry and Food and Drug Administration | PDF (358.91 KB) | Premarket, 510(k), Biologics, Medical Devices | Final | 09/20/2019 | |
| 96 | 特殊510(k)计划：行业和食品药品监督管理局工作人员指南 | The Special 510(k) Program: Guidance for Industry and Food and Drug Administration Staff | PDF (672.44 KB) | Premarket, 510(k), Administrative / Procedural, Biologics, Medical Devices | Final | 09/13/2019 | |
| 97 | 人道主义使用设备（HUD）指定：行业和食品药品监督管理局工作人员的指导 | Humanitarian Use Device (HUD) Designations : Guidance for Industry and Food and Drug Administration Staff | PDF (349.8 KB) | Premarket, Biologics, Medical Devices, Good Clinical Practice (GCP) | Final | 09/05/2019 | |
| 98 | 在医疗器械上市前批准和新分类时进行利益-风险评估时需考虑的因素：针对行业和食品药品监督管理局工作人员的指导 | Factors to Consider When Making Benefit-Risk Determinations in Medical Device Premarket Approval and De Novo Classifications: Guidance for Industry and Food and Drug Administration Staff | PDF (642.92 KB) | Premarket, Biologics, Medical Devices, Premarket Approval (PMA) | Final | 08/30/2019 | |
| 99 | 组合产品的上市后安全报告：行业和FDA工作人员指南 | Postmarketing Safety Reporting for Combination Products: Guidance for Industry and FDA Staff | PDF (620.95 KB) | Biologics, Drugs, Medical Devices, Combination Products | Final | 07/22/2019 | |
| 100 | 在研究性器械豁免（IDE）临床试验期间的现场案例展示：针对机构审查委员会、行业、临床研究者和食品药品监督管理局工作人员的指导 | Live Case Presentations During Investigational Device Exemption (IDE) Clinical Trials: Guidance for Institutional Review Boards, Industry, Clinical Investigators, and Food and Drug Administration Staff | PDF (345.35 KB) | Premarket, Good Clinical Practice (GCP), Pediatric Product Development, Investigational Device Exemption (IDE), Medical Devices | Final | 07/11/2019 | |
| 101 | 某些透视设备要求的政策澄清：针对行业和食品药品管理局工作人员的指导 | Policy Clarification for Certain Fluoroscopic Equipment Requirements: Guidance for Industry and Food and Drug Administration Staff | PDF (336.85 KB) | Medical Devices, Radiation-Emitting Products, Radiological Health | Final | 05/08/2019 | |
| 102 | 超高分子量聚乙烯（UHMWPE）在骨科设备中的表征：行业和食品药品监督管理局工作人员的指导 | Characterization of Ultrahigh Molecular Weight Polyethylene (UHMWPE) Used in Orthopedic Devices: Guidance for Industry and Food and Drug Administration Staff | PDF (519.76 KB) | 510(k), Premarket Approval (PMA), Investigational Device Exemption (IDE), Medical Devices, Orthopedic | Final | 04/26/2019 | |
| 103 | 组合产品上市后安全报告合规政策：立即生效的行业和食品药品监督管理局工作人员指导 | Compliance Policy for Combination Product Postmarketing Safety Reporting: Immediately in Effect Guidance for Industry and Food and Drug Administration Staff | PDF (57.6 KB) | Biologics, Drugs, Medical Devices, Combination Products | Final | 04/21/2019 | |
| 104 | ORA实验室分析结果的发布给责任方：食品和药物管理局工作人员的指导 | Release of ORA Laboratory Analytical Results to the Responsible Party: Guidance for Food and Drug Administration Staff | PDF (69.02 KB) | Investigation & Enforcement, Administrative / Procedural, Animal & Veterinary, Biologics, Cosmetics, Dietary Supplements, Drugs, Food & Beverages, Medical Devices, Radiation-Emitting Products, Tobacco | Final | 03/01/2019 | |
| 105 | 意图豁免某些未分类医疗设备的上市前通知要求：行业和食品药品监督管理局工作人员的指导 | Intent to Exempt Certain Unclassified Medical Devices from Premarket Notification Requirements: Guidance for Industry and Food and Drug Administration Staff | PDF (240.59 KB) | Premarket, 510(k), Anesthesiology , Physical Medicine, Orthopedic, Ophthalmic, Obstetrical & Gynecological, Neurological, Cardiovascular , General Hospital & Personal Use , General & Plastic Surgery , Gastroenterology-Urology , Ear, Nose & Throat , Dental , Medical Devices | Final | 02/08/2019 | |
| 106 | 最少负担条款：概念与原则：行业和FDA工作人员的指导 | The Least Burdensome Provisions: Concept and Principles: Guidance for Industry and FDA Staff | PDF (483.29 KB) | Premarket, Biologics, Medical Devices | Final | 02/05/2019 | |
| 107 | 制造地点变更补充材料：内容和提交：行业和食品药品管理局工作人员指南 | Manufacturing Site Change Supplements: Content and Submission: Guidance for Industry and Food and Drug Administration Staff | PDF (264.12 KB) | Postmarket, Biologics, Medical Devices, Premarket Approval (PMA) | Final | 12/17/2018 | |
| 108 | 在确定具有不同技术特征的上市前通知（510(k)）的实质等同性时需要考虑的利益-风险因素：针对行业和食品药品监督管理局工作人员的指导 | Benefit-Risk Factors to Consider When Determining Substantial Equivalence in Premarket Notifications (510(k)) with Different Technological Characteristics: Guidance for Industry and Food and Drug Administration Staff | PDF (537.58 KB) | 510(k), Biologics, Medical Devices | Final | 09/25/2018 | |
| 109 | 在医疗器械的上市前提交中适当使用自愿共识标准：针对行业和食品药品监督管理局工作人员的指导 | Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices: Guidance for Industry and Food and Drug Administration Staff | PDF (400.61 KB) | Postmarket, Premarket, Administrative / Procedural, Medical Devices, Radiation-Emitting Products | Final | 09/14/2018 | |
| 110 | 体外诊断测试的逻辑观察标识符名称和代码：行业和食品药品监督管理局工作人员的指导 | Logical Observation Identifiers Names and Codes for In Vitro Diagnostic Tests : Guidance for Industry and Food and Drug Administration Staff | PDF (322.78 KB) | Biologics, Medical Devices, Labeling, Laboratory Tests, IVDs (In Vitro Diagnostic Devices), Digital Health | Final | 06/15/2018 | |
| 111 | 与FDA要求标签一致的医疗产品传播——问答：行业指南 | Medical Product Communications That Are Consistent With the FDA-Required Labeling — Questions and Answers : Guidance for Industry | PDF (328.9 KB) | Administrative / Procedural, Animal & Veterinary, Biologics, Drugs, Medical Devices | Final | 06/13/2018 | |
| 112 | 针对下一代测序（NGS）基础的体外诊断（IVD）设计、开发和分析验证的考虑，旨在帮助诊断疑似胚系疾病：供利益相关者和食品药品监督管理局工作人员参考的指导。 | Considerations for Design, Development, and Analytical Validation of Next Generation Sequencing (NGS) - Based In Vitro Diagnostics (IVDs) Intended to Aid in the Diagnosis of Suspected Germline Diseases: Guidance for Stakeholders and Food and Drug Administration Staff | PDF (868.7 KB) | Biologics, Medical Devices | Final | 04/13/2018 | |
| 113 | 产品追溯行业指导的数据和文档实践标准化 | Standardization of Data and Documentation Practices for Product Tracing Guidance for Industry | PDF (170.08 KB) | Administrative / Procedural, Biologics, Drugs, Medical Devices | Draft | 03/02/2018 | |
| 114 | 医疗器械配件 - 描述配件和分类路径：行业和FDA工作人员指南 | Medical Device Accessories - Describing Accessories and Classification Pathways: Guidance for Industry and FDA Staff | PDF (442.1 KB) | Premarket, Administrative / Procedural, Biologics, Medical Devices, Digital Health | Final | 12/20/2017 | |
| 115 | 医疗设备软件（SAMD）：临床评估：行业和食品药品监督管理局工作人员指南 | Software as a Medical Device (SAMD): Clinical Evaluation: Guidance for Industry and Food and Drug Administration Staff | PDF (1.23 MB) | Premarket, International, Medical Devices | Final | 12/08/2017 | |
| 116 | 增材制造医疗设备的技术考虑：行业和食品药品监督管理局工作人员的指导 | Technical Considerations for Additive Manufactured Medical Devices: Guidance for Industry and Food and Drug Administration Staff | PDF (802.88 KB) | Premarket, Biotechnology, 510(k), Premarket Approval (PMA), Investigational Device Exemption (IDE), HUD/HDE, Biologics, Medical Devices, Orthopedic, Tissue | Final | 12/05/2017 | |
| 117 | 唯一设备识别：设备的直接标记：行业和食品药品监督管理局工作人员的指导 | Unique Device Identification: Direct Marking of Devices : Guidance for Industry and Food and Drug Administration Staff | PDF (586.68 KB) | Biologics, Medical Devices, Labeling, UDI | Final | 11/17/2017 | |
| 118 | 某些超声外科吸引器设备的产品标签：行业和食品药品监督管理局工作人员的指导 | Product Labeling for Certain Ultrasonic Surgical Aspirator Devices: Guidance for Industry and Food and Drug Administration Staff | PDF (273 KB) | Premarket, 510(k), Labeling, Safety - Issues, Errors, and Problems, Medical Devices, Obstetrical & Gynecological, General & Plastic Surgery | Final | 10/30/2017 | |
| 119 | 决定何时提交现有设备软件变更的510(k)：针对行业和食品药品监督管理局工作人员的指导 | Deciding When to Submit a 510(k) for a Software Change to an Existing Device: Guidance for Industry and Food and Drug Administration Staff | PDF (585.18 KB) | Premarket, 510(k), Biologics, Medical Devices, Labeling, Laboratory Tests, IVDs (In Vitro Diagnostic Devices), Digital Health | Final | 10/25/2017 | |
| 120 | 机构审查委员会（IRB）会议记录：机构和IRB的指导 | Minutes of Institutional Review Board (IRB) Meetings: Guidance for Institutions and IRBs | PDF (117.59 KB) | Investigation & Enforcement, Biologics, Drugs, Medical Devices, Good Clinical Practice (GCP), Pediatric Product Development | Final | 09/25/2017 | |
| 121 | 医疗器械临床研究中年龄、种族和民族特定数据的评估与报告：行业和食品药品监督管理局工作人员的指导 | Evaluation and Reporting of Age-, Race-, and Ethnicity-Specific Data in Medical Device Clinical Studies: Guidance for Industry and Food and Drug Administration Staff | PDF (1.1 MB) | Premarket, 510(k), Premarket Approval (PMA), Investigational Device Exemption (IDE), HUD/HDE, Biologics, Medical Devices, Radiation-Emitting Products, Clinical - Medical, Good Clinical Practice (GCP), Labeling, Pediatric Product Development, Laboratory Tests, IVDs (In Vitro Diagnostic Devices), Physical Medicine, Orthopedic, Ophthalmic, Obstetrical & Gynecological, Neurological, Molecular and Clinical Genetics, Immunology & Microbiology , Cardiovascular , Hematology & Pathology , General Hospital & Personal Use , General & Plastic Surgery , Gastroenterology-Urology , Ear, Nose & Throat , Dental , Clinical Chemistry & Clinical Toxicology , Radiology, Radiological Health | Final | 09/12/2017 | |
| 122 | 医疗器械咨询委员会会议程序：行业和食品药品管理局工作人员指南 | Procedures for Meetings of the Medical Devices Advisory Committee: Guidance for Industry and Food and Drug Administration Staff | PDF (443.17 KB) | Premarket, Advisory Committees, 510(k), Premarket Approval (PMA), HUD/HDE, Administrative / Procedural, Labeling, Safety - Issues, Errors, and Problems, Anesthesiology , Laboratory Tests, IVDs (In Vitro Diagnostic Devices), Physical Medicine, Orthopedic, Ophthalmic, Obstetrical & Gynecological, Neurological, Molecular and Clinical Genetics, Immunology & Microbiology , Cardiovascular , Hematology & Pathology , General Hospital & Personal Use , General & Plastic Surgery , Gastroenterology-Urology , Ear, Nose & Throat , Dental , Clinical Chemistry & Clinical Toxicology , Radiology, Laser Notice, Medical Devices | Final | 09/01/2017 | |
| 123 | 在进行医疗器械研究设备豁免的利益-风险评估时需考虑的因素：针对研究设备豁免赞助者、赞助-研究者和食品药品监督管理局工作人员的指导。 | Factors to Consider When Making Benefit-Risk Determinations for Medical Device Investigational Device Exemptions: Guidance for Investigational Device Exemption Sponsors, Sponsor-Investigators and Food and Drug Administration Staff | PDF (748.9 KB) | Premarket, Biologics, Medical Devices, Clinical - Medical, Investigational Device Exemption (IDE) | Final | 01/13/2017 | |
| 124 | 医疗设备网络安全的市场后管理：行业和食品药品监督管理局工作人员的指导 | Postmarket Management of Cybersecurity in Medical Devices: Guidance for Industry and Food and Drug Administration Staff | PDF (1.23 MB) | Postmarket, Premarket, 510(k), Premarket Approval (PMA), Digital Health, Labeling, Safety - Issues, Errors, and Problems, Medical Devices | Final | 12/28/2016 | |
| 125 | 在临床研究中使用电子知情同意 - 问题与答案：供机构审查委员会、研究者和赞助者参考的指南 | Use of Electronic Informed Consent in Clinical Investigations – Questions and Answers: Guidance for Institutional Review Boards, Investigators, and Sponsors | PDF (230.82 KB) | Administrative / Procedural, Biologics, Drugs, Medical Devices | Final | 12/15/2016 | |
| 126 | 减轻通过柔性胃肠内窥镜使用的阀门和配件造成的交叉污染风险：行业和食品药品监督管理局工作人员的指导 | Mitigating the Risk of Cross-Contamination from Valves and Accessories Used for Irrigation Through Flexible Gastrointestinal Endoscopes: Guidance for Industry and Food and Drug Administration Staff | PDF (445.11 KB) | Premarket, Gastroenterology-Urology , Medical Devices | Final | 11/29/2016 | |
| 127 | 神经设备针对疾病进展和临床结果的研究性设备豁免（IDE）的临床考虑：针对行业和食品药品监督管理局工作人员的指导 | Clinical Considerations for Investigational Device Exemptions (IDEs) for Neurological Devices Targeting Disease Progression and Clinical Outcomes: Guidance for Industry and Food and Drug Administration Staff | PDF (176.87 KB) | Premarket, Advisory Committees, 510(k), Premarket Approval (PMA), HUD/HDE, Clinical - Medical, Good Clinical Practice (GCP), Labeling, Safety - Issues, Errors, and Problems, Laser Notice, Medical Devices, Neurological | Final | 11/07/2016 | |
| 128 | 临床试验中种族和民族数据的收集：行业和食品药品监督管理局工作人员的指导 | Collection of Race and Ethnicity Data in Clinical Trials: Guidance for Industry and Food and Drug Administration Staff | PDF (896.11 KB) | Biologics, Drugs, Medical Devices, Clinical - Medical, Good Clinical Practice (GCP), Investigational Device Exemption (IDE) | Final | 10/26/2016 | |
| 129 | 固态X射线成像设备510(k)提交指南：行业和食品药品监督管理局工作人员指南 | Guidance for the Submission of 510(k)s for Solid State X-ray Imaging Devices: Guidance for Industry and Food and Drug Administration Staff | PDF (388.18 KB) | Premarket, 510(k), Medical Devices, Radiation-Emitting Products, Radiological Health, Radiology | Final | 09/01/2016 | |
| 130 | 用于普通外科的双极电外科血管封闭器的上市前通知（510(k)）提交：行业和食品药品监督管理局工作人员的指导 | Premarket Notification (510(k)) Submissions for Bipolar Electrosurgical Vessel Sealers for General Surgery: Guidance for Industry and Food and Drug Administration Staff | PDF (450.4 KB) | Premarket, 510(k), Clinical - Medical, Good Clinical Practice (GCP), Labeling, General & Plastic Surgery , Medical Devices | Final | 08/15/2016 | |
| 131 | 体外伴随诊断设备与治疗产品的共同开发原则：行业和食品药品管理局工作人员的草案指导 | Principles for Codevelopment of an In Vitro Companion Diagnostic Device with a Therapeutic Product: Draft Guidance for Industry and Food and Drug Administration Staff | PDF (1.1 MB) | Premarket, 510(k), Premarket Approval (PMA), Biologics, Drugs, Medical Devices, Laboratory Tests, IVDs (In Vitro Diagnostic Devices) | Draft | 07/15/2016 | |
| 132 | 利用现有临床数据推断医疗器械在儿科用途中的应用：行业和食品药品监督管理局工作人员的指导 | Leveraging Existing Clinical Data for Extrapolation to Pediatric Uses of Medical Devices: Guidance for Industry and Food and Drug Administration Staff | PDF (367.42 KB) | Premarket, Biologics, Medical Devices, Good Clinical Practice (GCP), Pediatric Product Development, Premarket Approval (PMA), HUD/HDE | Final | 06/21/2016 | |
| 133 | 辐射生物剂量测定医疗对策设备：行业和食品药品管理局工作人员的指导 | Radiation Biodosimetry Medical Countermeasure Devices: Guidance for Industry and Food and Drug Administration Staff | PDF (514.01 KB) | Premarket, Emergencies, Laboratory Tests, IVDs (In Vitro Diagnostic Devices), Medical Devices, Radiation-Emitting Products, Radiological Health | Final | 04/18/2016 | |
| 134 | 医疗器械和临床试验设计用于治疗或改善真菌感染指甲的外观：行业和食品药品监督管理局工作人员的指导 | Medical Devices and Clinical Trial Design for the Treatment or Improvement in the Appearance of Fungally-Infected Nails: Guidance for Industry and Food and Drug Administration Staff | PDF (215.75 KB) | Premarket, 510(k), Premarket Approval (PMA), Investigational Device Exemption (IDE), HUD/HDE, General & Plastic Surgery , Good Clinical Practice (GCP), Labeling, Medical Devices | Final | 03/07/2016 | |
| 135 | 将人因工程和可用性工程应用于医疗设备：行业和食品药品监督管理局工作人员的指导 | Applying Human Factors and Usability Engineering to Medical Devices: Guidance for Industry and Food and Drug Administration Staff | PDF (918.39 KB) | Postmarket, Premarket, 510(k), Premarket Approval (PMA), Anesthesiology , Laboratory Tests, IVDs (In Vitro Diagnostic Devices), Physical Medicine, Orthopedic, Ophthalmic, Obstetrical & Gynecological, Neurological, Molecular and Clinical Genetics, Immunology & Microbiology , Cardiovascular , Hematology & Pathology , General Hospital & Personal Use , General & Plastic Surgery , Gastroenterology-Urology , Ear, Nose & Throat , Digital Health, Dental , Clinical Chemistry & Clinical Toxicology , Radiology, Labeling, Safety - Issues, Errors, and Problems, Medical Devices | Final | 02/03/2016 | |
| 136 | 植入式血液透析通路装置：行业和食品药品监督管理局工作人员指南 | Implanted Blood Access Devices for Hemodialysis: Guidance for Industry and Food and Drug Administration Staff | PDF (709.54 KB) | Medical Devices | Final | 01/21/2016 | |
| 137 | 医疗环境中使用的外科服的上市前通知要求：行业和食品药品监督管理局工作人员的指导 | Premarket Notification Requirements Concerning Gowns Intended for Use in Health Care Settings: Guidance for Industry and Food and Drug Administration Staff | PDF (318.85 KB) | Medical Devices | Final | 12/09/2015 | |
| 138 | 一次性眼内眼科设备的内毒素检测建议 | Endotoxin Testing Recommendations for Single-Use Intraocular Ophthalmic Devices | PDF (418.97 KB) | Premarket, Medical Devices, Ophthalmic | Final | 08/17/2015 | |
| 139 | 平衡需预市场批准的设备的预市场和后市场数据收集：行业和食品药品监督管理局工作人员的指导 | Balancing Premarket and Postmarket Data Collection for Devices Subject to Premarket Approval: Guidance for Industry and Food and Drug Administration Staff | PDF (500.14 KB) | Postmarket, Premarket, Biologics, Medical Devices, Premarket Approval (PMA) | Final | 04/13/2015 | |
| 140 | 安全考虑以减轻小口径连接器在肠内应用中误连接的风险：行业和食品药品监督管理局工作人员的指导 | Safety Considerations to Mitigate the Risks of Misconnections with Small-bore Connectors Intended for Enteral Applications: Guidance for Industry and Food and Drug Administration Staff | PDF (141.95 KB) | Premarket, 510(k), Medical Devices | Final | 02/11/2015 | |
| 141 | 输液泵产品生命周期总览：行业和FDA工作人员指南 | Infusion Pumps Total Product Life Cycle: Guidance for Industry and FDA Staff | PDF (577.19 KB) | Premarket, 510(k), Medical Devices | Final | 12/02/2014 | |
| 142 | 家庭使用设备的设计考虑：行业和食品药品监督管理局工作人员的指导 | Design Considerations for Devices Intended for Home Use: Guidance for Industry and Food and Drug Administration Staff | PDF (522.91 KB) | Premarket, Medical Devices | Final | 11/24/2014 | |
| 143 | 区分医疗器械召回与医疗器械改进：行业和食品药品监督管理局工作人员的指导 | Distinguishing Medical Device Recalls from Medical Device Enhancements: Guidance for Industry and Food and Drug Administration Staff | PDF (359.71 KB) | Postmarket, Medical Devices | Final | 10/15/2014 | |
| 144 | 高度多重化的微生物/医学对策体外核酸基础诊断设备：行业和食品药品管理局工作人员的指导 | Highly Multiplexed Microbiological/Medical Countermeasure In Vitro Nucleic Acid Based Diagnostic Devices: Guidance for Industry and Food and Drug Administration Staff | PDF (798.55 KB) | Laboratory Tests, IVDs (In Vitro Diagnostic Devices), Medical Devices | Final | 08/27/2014 | |
| 145 | 唯一设备标识符系统：常见问题解答，第1卷：行业和食品药品监督管理局员工指南 | Unique Device Identifier System: Frequently Asked Questions, Vol. 1 : Guidance for Industry and Food and Drug Administration Staff | PDF (462.01 KB) | Biologics, Medical Devices, Labeling, UDI | Final | 08/20/2014 | |
| 146 | 独特设备识别系统：小型实体合规指南：行业和食品药品监督管理局工作人员的指导 | Unique Device Identification System: Small Entity Compliance Guide: Guidance for Industry and Food and Drug Administration Staff | PDF (419.86 KB) | Biologics, Medical Devices, Labeling | Final | 08/13/2014 | |
| 147 | 510(k)计划：评估上市前通知中的实质等同性[510(k)]：行业和食品药品管理局工作人员指南 | The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)]: Guidance for Industry and Food and Drug Administration Staff | PDF (843.9 KB) | Premarket, 510(k), Administrative / Procedural, Medical Devices | Final | 07/28/2014 | |
| 148 | 磁共振诊断设备重大风险调查标准 - 产业和食品药品监督管理局工作人员指南 | Criteria for Significant Risk Investigations of Magnetic Resonance Diagnostic Devices - Guidance for Industry and Food and Drug Administration Staff | PDF (77.94 KB) | Premarket, Medical Devices | Final | 06/20/2014 | |
| 149 | 提供关于医疗器械在儿科用途的信息：行业和FDA工作人员的指导 | Providing Information about Pediatric Uses of Medical Devices: Guidance for Industry and FDA Staff | PDF (370.53 KB) | Premarket, Biologics, Medical Devices, Pediatric Product Development | Final | 05/01/2014 | |
| 150 | 医疗器械追踪：行业和FDA工作人员指南 | Medical Device Tracking : Guidance for Industry and FDA Staff | PDF (291.45 KB) | Medical Devices | Final | 03/27/2014 | |
| 151 | 关于电子医疗设备报告（eMDR） - 针对行业、用户设施和FDA工作人员的指导问答 | Questions and Answers about eMDR - Electronic Medical Device Reporting - Guidance for Industry, User Facilities and FDA Staff | PDF (147.41 KB) | Adverse Event Reporting System (FAERS), Adverse Event Reporting, Medical Devices | Final | 02/14/2014 | |
| 152 | 医疗器械关键临床研究的设计考虑：针对行业、临床研究者、机构审查委员会和FDA工作人员的指导 | Design Considerations for Pivotal Clinical Investigations for Medical Devices: Guidance for Industry, Clinical Investigators, Institutional Review Boards and FDA Staff | PDF (402.07 KB) | Premarket, Biologics, Medical Devices, Good Clinical Practice (GCP), Investigational Device Exemption (IDE) | Final | 11/07/2013 | |
| 153 | 临床研究中的电子源数据：行业指南 | Electronic Source Data in Clinical Investigations: Guidance for Industry | PDF (190.31 KB) | Administrative / Procedural, Good Clinical Practice (GCP), Biologics, Drugs, Medical Devices | Final | 09/18/2013 | |
| 154 | 临床研究监督——基于风险的监测方法：行业指南 | Oversight of Clinical Investigations — A Risk-Based Approach to Monitoring: Guidance for Industry | PDF (382.77 KB) | Investigation & Enforcement, Administrative / Procedural, Good Clinical Practice (GCP), Biologics, Drugs, Medical Devices | Final | 08/07/2013 | |
| 155 | 体外诊断设备的检测迁移研究：行业和FDA工作人员指南 | Assay Migration Studies for In Vitro Diagnostic Devices: Guidance for Industry and FDA Staff | PDF (1.21 MB) | Premarket, Laboratory Tests, IVDs (In Vitro Diagnostic Devices), Medical Devices | Final | 04/25/2013 | |
| 156 | 紧急研究知情同意要求的例外：针对机构审查委员会、临床研究者和赞助商的指导 | Exception from Informed Consent Requirements for Emergency Research: Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors | PDF (340.91 KB) | Biologics, Drugs, Medical Devices, Good Clinical Practice (GCP) | Final | 04/01/2013 | |
| 157 | 视网膜假体的研究设备豁免（IDE）指南：针对行业和FDA工作人员的指南 | Investigational Device Exemption (IDE) Guidance for Retinal Prostheses: Guidance for Industry and FDA Staff | PDF (168.79 KB) | Investigational Device Exemption (IDE), Medical Devices, Ophthalmic | Final | 03/06/2013 | |
| 158 | 心房颤动治疗外科消融设备的临床研究设计 - 对行业和食品药品监督管理局工作人员的指导 | Clinical Study Designs for Surgical Ablation Devices for Treatment of Atrial Fibrillation - Guidance for Industry and Food and Drug Administration Staff | PDF (169.08 KB) | Premarket, Medical Devices | Final | 02/15/2013 | |
| 159 | 临床研究者的财务披露：临床研究者、行业和FDA工作人员的指导 | Financial Disclosure by Clinical Investigators: Guidance for Clinical Investigators, Industry,and FDA Staff | PDF (165.38 KB) | Biologics, Drugs, Medical Devices, Good Clinical Practice (GCP), Investigational Device Exemption (IDE) | Final | 02/01/2013 | |
| 160 | 合规政策指南第390.200节：秘书确定产品不符合规定或存在缺陷 - 21 CFR 1003.11 | Compliance Policy Guide Sec. 390.200 Determination by Secretary that Product Fails to Comply or has Defect - 21 CFR 1003.11 | PDF (44.63 KB) | Investigation & Enforcement, Medical Devices | Final | 11/01/2012 | |
| 161 | 建立体外诊断设备用于检测或检测和区分流感病毒的性能特征 - 行业和FDA工作人员指南 | Establishing the Performance Characteristics of In Vitro Diagnostic Devices for the Detection or Detection and Differentiation of Influenza Viruses - Guidance for Industry and FDA Staff | PDF (289.02 KB) | Medical Devices, Pediatric Product Development | Final | 07/15/2011 | |
| 162 | 血液采样针标签 - 行业和食品药品监督管理局工作人员指南 | Blood Lancet Labeling - Guidance for Industry and Food and Drug Administration Staff | PDF (39.59 KB) | Premarket, Medical Devices | Final | 11/29/2010 | |
| 163 | 抗冲击镜片：问答：行业和FDA工作人员的指导 | Impact-Resistant Lenses: Questions and Answers: Guidance for Industry and FDA Staff | PDF (135.12 KB) | Medical Devices | Final | 09/02/2010 | |
| 164 | 体外诊断（IVD）设备研究 - 常见问题：行业和FDA工作人员指南 | In Vitro Diagnostic (IVD) Device Studies - Frequently Asked Questions: Guidance for Industry and FDA Staff | PDF (352.1 KB) | Premarket, Biologics, Medical Devices, Good Clinical Practice (GCP), Laboratory Tests, IVDs (In Vitro Diagnostic Devices) | Final | 06/25/2010 | |
| 165 | 医疗器械临床试验中贝叶斯统计使用指南（PDF版本） | Guidance for the Use of Bayesian Statistics in Medical Device Clinical Trials (PDF Version) | PDF (341.52 KB) | Premarket, Medical Devices, Radiation-Emitting Products | Final | 02/05/2010 | |
| 166 | 患者报告的结果测量：在医疗产品开发中支持标签声明的使用：行业指南 | Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims: Guidance for Industry | PDF (295 KB) | Biologics, Drugs, Medical Devices, Clinical - Medical, Good Clinical Practice (GCP) | Final | 12/09/2009 | |
| 167 | 不良事件报告给伦理审查委员会 — 改善人类受试者保护：临床研究者、赞助商和伦理审查委员会的指导 | Adverse Event Reporting to IRBs — Improving Human Subject Protection: Guidance for Clinical Investigators, Sponsors, and IRBs | PDF (56.53 KB) | Administrative / Procedural, Good Clinical Practice (GCP), Biologics, Drugs, Medical Devices | Final | 01/14/2009 | |
| 168 | 对需预市场批准（PMA）设备的修改 - PMA补充决策过程：行业和FDA工作人员的指导 | Modifications to Devices Subject to Premarket Approval (PMA) - The PMA Supplement Decision-Making Process: Guidance for Industry and FDA Staff | PDF (660.23 KB) | Premarket, Biologics, Medical Devices, Premarket Approval (PMA) | Final | 12/11/2008 | |
| 169 | 血管内给药装置上市前通知提交 [510(k)]: 行业和FDA工作人员指南 | Intravascular Administration Sets Premarket Notification Submissions [510(k)]: Guidance for Industry and FDA Staff | PDF (317.03 KB) | Premarket, 510(k), Medical Devices | Final | 07/11/2008 | |
| 170 | 对外科医生和/或患者检查手套进行监测和拘留而不进行物理检查：行业和FDA工作人员的指导 | Surveillance and Detention Without Physical Examination of Surgeons' and/or Patient Examination Gloves: Guidance for Industry and FDA Staff | PDF (79.52 KB) | Postmarket, Medical Devices | Final | 07/11/2008 | |
| 171 | 夜间家庭血液透析设备的研究性设备豁免（IDE）：针对行业和FDA工作人员的指导 | Investigational Device Exemptions (IDEs) for Devices Indicated for Nocturnal Home Hemodialysis: Guidance for Industry and FDA Staff | PDF (196.53 KB) | Premarket, Investigational Device Exemption (IDE), Medical Devices | Final | 04/15/2008 | |
| 172 | 无菌产品稳定性方案中作为无菌测试替代的容器和封闭系统完整性测试：行业指导 | Container and Closure System Integrity Testing in Lieu of Sterility Testing as a Component of the Stability Protocol for Sterile Products: Guidance for Industry | PDF (64.2 KB) | Postmarket, Administrative / Procedural, Animal & Veterinary, Biologics, Drugs, Medical Devices | Final | 02/25/2008 | |
| 173 | 医疗手套指导手册：行业和FDA工作人员的指导 | Medical Glove Guidance Manual: Guidance for Industry and FDA Staff | PDF (770.76 KB) | Premarket, 510(k), Medical Devices | Final | 01/22/2008 | |
| 174 | 辐射发射电子产品的检查和现场测试：附件A | Inspection and Field Testing of Radiation-Emitting Electronic Products: Attachment A | FDA-2020-D-0957 | Postmarket, Medical Devices, Radiation-Emitting Products | Final | 10/31/2007 | |
| 175 | 生物指示剂（BI）上市前通知[510(k)]提交：行业和FDA工作人员指南 | Biological Indicator (BI) Premarket Notification [510(k)] Submissions : Guidance for Industry and FDA Staff | PDF (189.01 KB) | Premarket, 510(k), Medical Devices | Final | 10/04/2007 | |
| 176 | 柜式X射线系统合规指南 | Compliance Guide for Cabinet X-Ray Systems | PDF (624.92 KB) | Medical Devices, Radiation-Emitting Products | Final | 09/19/2007 | |
| 177 | 商业分销的分析物特异性试剂（ASRs）：常见问题解答：行业和FDA工作人员指南 | Commercially Distributed Analyte Specific Reagents (ASRs): Frequently Asked Questions: Guidance for Industry and FDA Staff | PDF (138.61 KB) | Premarket, Good Clinical Practice (GCP), Medical Devices | Final | 09/14/2007 | |
| 178 | 激光产品 - 符合IEC 60825-1和IEC 60601-2-22；（激光通知第50号） | Laser Products - Conformance with IEC 60825-1 and IEC 60601-2-22; (Laser Notice No. 50) | PDF (307.4 KB) | Postmarket, Laser Notice, Laser Notice, Medical Devices, Radiation-Emitting Products | Final | 06/24/2007 | |
| 179 | 神经血栓切除设备的临床前和临床研究：行业和FDA工作人员的指导 | Pre-Clinical and Clinical Studies for Neurothrombectomy Devices: Guidance for Industry and FDA Staff | PDF (118.87 KB) | Premarket, Good Clinical Practice (GCP), Medical Devices | Final | 06/18/2007 | |
| 180 | 激光产品替代标签批准（激光通知53） | Approval of Alternate Means of Labeling for Laser Products (Laser Notice 53) | PDF (31.62 KB) | Medical Devices, Radiation-Emitting Products | Final | 03/23/2007 | |
| 181 | 补充和替代医学产品及其食品和药物管理局的监管：行业草案指导 | Complementary and Alternative Medicine Products and their Regulation by the Food and Drug Administration: Draft Guidance for Industry | PDF (123.98 KB) | Premarket, Administrative / Procedural, Biologics, Cosmetics, Dietary Supplements, Drugs, Food & Beverages, Medical Devices, Food & Color Additives | Draft | 02/27/2007 | |
| 182 | CPG第100.550节 合同灭菌器的状态和责任，涉及药物和设备的灭菌 | CPG Sec. 100.550 Status and Responsibilities of Contract Sterilizers Engaged in the Sterilization of Drugs and Devices | FDA-2020-D-0957 | Investigation & Enforcement, Biologics, Drugs, Medical Devices | Final | 10/03/2006 | |
| 183 | 遵守2002年医疗器械用户费用和现代化法案第301条（修订版）——一次性设备制造商的显著和明显标识：行业和FDA工作人员指南 | Compliance with Section 301 of the Medical Device User Fee and Modernization Act of 2002, as amended – Prominent and Conspicuous Mark of Manufacturers on Single-Use Devices: Guidance for Industry and FDA Staff | PDF (250 KB) | Postmarket, User Fees, Labeling, Medical Devices | Final | 05/01/2006 | |
| 184 | 临床试验数据监测委员会的建立与运作：临床试验赞助者指南 | Establishment and Operation of Clinical Trial Data Monitoring Committees: Guidance for Clinical Trial Sponsors | PDF (395.28 KB) | Biologics, Drugs, Medical Devices, Clinical - Medical, Good Clinical Practice (GCP) | Final | 03/28/2006 | |
| 185 | 眼压计 - 市场前通知 [510(k)] 提交：行业和FDA工作人员指南 | Tonometers - Premarket Notification [510(k)] Submissions : Guidance for Industry and FDA Staff | PDF (232.63 KB) | Premarket, 510(k), Medical Devices | Final | 03/27/2006 | |
| 186 | 药物基因组学测试和遗传标记的遗传测试：行业和FDA工作人员的指导 | Pharmacogenetic Tests and Genetic Tests for Heritable Markers: Guidance for Industry and FDA Staff | PDF (66.47 KB) | Premarket, Biologics, Drugs, Medical Devices | Final | 02/09/2006 | |
| 187 | 关于医疗器械的常见问题：供伦理审查委员会、临床研究者和赞助商参考的指南 | Frequently Asked Questions About Medical Devices: Guidance For IRBs, Clinical Investigators, and Sponsors | PDF (266.36 KB) | Biologics, Medical Devices, Good Clinical Practice (GCP) | Final | 01/01/2006 | |
| 188 | 高强度汞蒸气放电灯性能标准的适用性（21 CFR 1040.30） | Applicability of the Performance Standard for High-Intensity Mercury Vapor Discharge Lamps (21 CFR 1040.30) | PDF (31.82 KB) | Medical Devices, Radiation-Emitting Products | Final | 11/06/2005 | |
| 189 | C-反应蛋白（CRP）、高灵敏度C-反应蛋白（hsCRP）和心脏C-反应检测的评估标准：行业和FDA工作人员的指导 | Review Criteria for Assessment of C-Reactive Protein (CRP), High Sensitivity C-Reactive Protein (hsCRP) and Cardiac C-Reactive Assays: Guidance for Industry and FDA Staff | PDF (175.75 KB) | Postmarket, Cardiovascular , Medical Devices | Final | 09/22/2005 | |
| 190 | 月经棉条和卫生巾：预市场通知提交（510(k)）的信息 - 行业和FDA工作人员的指导 | Menstrual Tampons and Pads: Information for Premarket Notification Submissions (510(k)s) - Guidance for Industry and FDA Staff | PDF (303.32 KB) | Premarket, 510(k), Medical Devices | Final | 07/27/2005 | |
| 191 | CPG第390.400节 受21 CFR 1000.15(a)报告要求的电子产品示例 | CPG Sec. 390.400 Examples of Electronic Products Subject to the Reporting Requirements Under 21 CFR 1000.15(a) | FDA-2020-D-0957 | Investigation & Enforcement, Administrative / Procedural, Medical Devices, Radiation-Emitting Products | Final | 03/01/2005 | |
| 192 | 药物基因组学数据提交：行业指南 | Pharmacogenomic Data Submissions: Guidance for Industry | PDF (179.08 KB) | Administrative / Procedural, Good Clinical Practice (GCP), Biologics, Drugs, Medical Devices | Final | 03/01/2005 | |
| 193 | 网络医疗设备中包含现成软件的网络安全：行业指南 | Cybersecurity for Networked Medical Devices Containing Off-the-Shelf (OTS) Software: Guidance for Industry | PDF (147.75 KB) | Medical Devices | Final | 01/14/2005 | |
| 194 | 临床试验考虑：用于治疗脊柱功能不全骨折的椎体增强装置 - 行业和FDA工作人员的指导 | Clinical Trial Considerations: Vertebral Augmentation Devices to Treat Spinal Insufficiency Fractures - Guidance for Industry and FDA Staff | FDA-2020-D-0957 | Premarket, Medical Devices | Final | 10/24/2004 | |
| 195 | 行业和FDA工作人员指南：脊柱系统510(k) | Guidance for Industry and FDA Staff: Spinal System 510(k)s | PDF (377.97 KB) | Premarket, Medical Devices | Final | 05/03/2004 | |
| 196 | 行业和FDA工作人员指南：声带中线设备 - 市场前通知[510(k)]提交 | Guidance for Industry and FDA Staff: Vocal Fold Medialization Devices - Premarket Notification [510(k)] Submissions | PDF (426.72 KB) | Premarket, Medical Devices | Final | 02/13/2004 | |
| 197 | 预市场批准申请模块化审查：行业和FDA工作人员指南 | Premarket Approval Application Modular Review: Guidance for Industry and FDA Staff | PDF (213.36 KB) | Premarket, Medical Devices | Final | 11/03/2003 | |
| 198 | 第11部分，电子记录；电子签名 - 范围和适用性：行业指导 | Part 11, Electronic Records; Electronic Signatures - Scope and Application: Guidance for Industry | PDF (43.9 KB) | Postmarket, Compliance, Electronic Submissions, Investigation & Enforcement, Administrative / Procedural, Current Good Manufacturing Practice (CGMP), Good Clinical Practice (GCP), Animal & Veterinary, Biologics, Cosmetics, Dietary Supplements, Drugs, Food & Beverages, Medical Devices, Radiation-Emitting Products, Tobacco, Food & Color Additives | Final | 09/05/2003 | |
| 199 | 儿童专家咨询小组 - 行业和FDA工作人员指南 | Pediatric Expertise for Advisory Panels - Guidance for Industry and FDA Staff | PDF (39.46 KB) | Advisory Committees, Medical Devices, Pediatric Product Development | Final | 06/03/2003 | |
| 200 | 特定上市申请审查的质量系统信息：行业和FDA工作人员的指导 | Quality System Information for Certain Premarket Application Reviews : Guidance for Industry and FDA Staff | PDF (548 KB) | Premarket, Medical Devices, Premarket Approval (PMA) | Final | 02/03/2003 | |
| 201 | 针刺 - 医疗器械报告指南，适用于用户设施、制造商和进口商 | Needlesticks - Medical Device Reporting Guidance for User Facilities, Manufacturers, and Importers | PDF (33.84 KB) | Adverse Event Reporting System (FAERS), Medical Devices | Final | 11/12/2002 | |
| 202 | 腹部和/或盆腔手术中可吸收粘连屏障装置的指导 - 行业指导 | Guidance for Resorbable Adhesion Barrier Devices for Use in Abdominal and/or Pelvic Surgery - Guidance for Industry | PDF (332.42 KB) | Premarket, Medical Devices | Final | 06/18/2002 | |
| 203 | 临床和外科使用的灭菌便利包：行业最终指导 | Sterilized Convenience Kits for Clinical and Surgical Use: Final Guidance for Industry | PDF (99.94 KB) | Postmarket, Medical Devices | Final | 01/07/2002 | |
| 204 | 关于第三方和医院再处理者对一次性设备的再处理和再利用的常见问题：针对行业和FDA工作人员的最终指导 | Frequently-Asked-Questions about the Reprocessing and Reuse of Single-Use Devices by Third-Party and Hospital Reprocessors: Final Guidance for Industry and FDA Staff | PDF (287.92 KB) | Premarket, Medical Devices | Final | 07/06/2001 | |
| 205 | 临床研究进行中的变更或修改；针对行业和CDRH工作人员的最终指导 | Changes or Modifications During the Conduct of a Clinical Investigation; Final Guidance for Industry and CDRH Staff | PDF (506.78 KB) | Premarket, Investigational Device Exemption (IDE), Medical Devices | Final | 05/29/2001 | |
| 206 | 医疗器械患者标签指导：针对行业和FDA工作人员的最终指导 | Guidance on Medical Device Patient Labeling: Final Guidance for Industry and FDA Staff | PDF (333.25 KB) | Labeling, Medical Devices | Final | 04/19/2001 | |
| 207 | 用于低温冲洗、运输和储存器官移植的研究设备豁免内容 - 行业和FDA审查者指南 | Content of Investigational Device Exemptions for Solutions for Hypothermic Flushing, Transport and Storage of Organs for Transplantation - Guidance for Industry and FDA Reviewers | PDF (133.33 KB) | Premarket, Investigational Device Exemption (IDE), Medical Devices | Final | 01/16/2001 | |
| 208 | 电子防盗系统标签：行业指导 | Labeling for Electronic Anti-Theft Systems: Guidance for Industry | PDF (23.05 KB) | Premarket, Labeling, Medical Devices | Final | 08/15/2000 | |
| 209 | 光发射近距离放射治疗源的上市前通知提交指南 - 行业指南 | Guidance for the Submission of Premarket Notifications for Photon-Emitting Brachytherapy Sources - Guidance for Industry | PDF (84.33 KB) | Premarket, Medical Devices | Final | 08/02/2000 | |
| 210 | 1-设备产品线的合并年度报告（1-CARD）- 行业和CDRH审查员的指导 | 1-Consolidated Annual Report for a Device product line (1-CARD) - Guidance for Industry and CDRH Reviewers | PDF (124.68 KB) | Medical Devices | Final | 07/06/2000 | |
| 211 | 制造商寻求耳鼻喉内窥镜护套作为保护屏障的市场准入指南：行业指南 | Guidance for Manufacturers Seeking Marketing Clearance of Ear, Nose, and Throat Endoscope Sheaths Used as Protective Barriers: Guidance for Industry | PDF (80.59 KB) | Premarket, Medical Devices | Final | 03/12/2000 | |
| 212 | 氮氧化物输送装置、氮氧化物分析仪和二氧化氮分析仪的上市前通知提交指导文件：行业和FDA审查员的指导 | Guidance Document for Premarket Notification Submissions for Nitric Oxide Delivery Apparatus, Nitric Oxide Analyzer and Nitrogen Dioxide Analyzer: Guidance for Industry and for FDA Reviewers | PDF (1.57 MB) | Premarket, 510(k), Medical Devices | Final | 01/24/2000 | |
| 213 | 脊柱系统IDE准备指导文件 - 针对行业和/或FDA工作人员的指导 | Guidance Document for the Preparation of IDEs for Spinal Systems - Guidance for Industry and/or FDA Staff | PDF (99.71 KB) | Labeling, Pediatric Product Development, Medical Devices | Final | 01/13/2000 | |
| 214 | 心血管血管内滤器510(k)提交指南 - 产业和FDA工作人员指南 | Guidance for Cardiovascular Intravascular Filter 510(k) Submissions - Guidance for Industry and FDA Staff | FDA-2020-D-0957 | Premarket, Cardiovascular , Medical Devices | Final | 11/26/1999 | |
| 215 | 推荐的心室心动过速消融临床研究设计 | Recommended Clinical Study Design for Ventricular Tachycardia Ablation | PDF (1.14 MB) | Medical Devices | Final | 05/07/1999 | |
| 216 | 准备研究性医疗器械可用性通知和招募研究对象：行业和FDA工作人员指南 | Preparing Notices of Availability of Investigational Medical Devices and for Recruiting Study Subjects: Guidance for Industry and FDA Staff | PDF (25.84 KB) | Premarket, Investigational Device Exemption (IDE), Medical Devices | Final | 03/19/1999 | |
| 217 | 皮肤磨削设备指南 - 行业指南 | Guidance for Dermabrasion Devices - Guidance for Industry | PDF (20.25 KB) | Premarket, Medical Devices | Final | 03/02/1999 | |
| 218 | 天然橡胶产品中化学物质皮肤过敏测试的上市前通知[510(k)]提交 - 行业和FDA审查员/工作人员指南 | Premarket Notification [510(k)] Submissions for Testing for Skin Sensitization To Chemicals In Natural Rubber Products - Guidance for Industry and FDA Reviewers/Staff | PDF (40.48 KB) | Premarket, Medical Devices | Final | 01/13/1999 | |
| 219 | 放射性核素剂量校准器预市场通知提交指南 - 行业指南 | Guidance for the Submission of Premarket Notifications For Radionuclide Dose Calibrators - Guidance for Industry | PDF (47.65 KB) | Premarket, Medical Devices | Final | 11/20/1998 | |
| 220 | 水性分流器 - 510(k) 提交 - 行业和FDA审查员/工作人员指南 | Aqueous Shunts - 510(k) Submissions - Guidance for Industry and for FDA Reviewers/Staff | PDF (57.2 KB) | Premarket, Medical Devices | Final | 11/16/1998 | |
| 221 | 心脏监测仪指导（包括心率计和速率警报） - 行业指导 | Cardiac Monitor Guidance (including Cardiotachometer and Rate Alarm) - Guidance for Industry | PDF (80.92 KB) | Premarket, Cardiovascular , Medical Devices | Final | 11/05/1998 | |
| 222 | 一般/特定预期用途 - 行业指南 | General/Specific Intended Use - Guidance for Industry | PDF (75.67 KB) | Premarket, Medical Devices, Pediatric Product Development | Final | 11/04/1998 | |
| 223 | 非处方太阳镜指导文件 - 行业指导 | Guidance Document For Nonprescription Sunglasses - Guidance for Industry | PDF (71.93 KB) | Premarket, Medical Devices | Final | 10/09/1998 | |
| 224 | OTC假牙垫、垫片、修复剂、修理工具包和部分制造假牙工具包 - 行业和FDA工作人员指南 | OTC Denture Cushions, Pads, Reliners, Repair Kits, and Partially Fabricated Denture Kits - Guidance for Industry and FDA Staff | PDF (93.73 KB) | Premarket, Medical Devices | Final | 08/18/1998 | |
| 225 | 修订的程序：将镜片加工实验室添加到针对可延长佩戴的III类刚性气体透过性隐形眼镜的批准前审批申请中 - 行业和FDA工作人员指南 | Revised Procedures for Adding Lens Finishing Laboratories to Approved Premarket Approval Applications for Class III Rigid Gas Permeable Contact Lenses for Extended Wear - Guidance for Industry and FDA Staff | PDF (46.55 KB) | Premarket, Medical Devices | Final | 08/11/1998 | |
| 226 | 统一避孕药标签 - 行业指导 | Uniform Contraceptive Labeling - Guidance for Industry | PDF (93.67 KB) | Premarket, Medical Devices | Final | 07/23/1998 | |
| 227 | 可重复使用医疗器械处理用洗涤机和洗涤消毒机指导文件 | Guidance Document For Washers And Washer-Disinfectors Intended For Processing Reusable Medical Devices | FDA-2020-D-0957 | Premarket, Medical Devices | Final | 06/02/1998 | |
| 228 | 食管和气管假体的上市前通知内容指导 - 行业指导 | Guidance For The Content Of Premarket Notifications For Esophageal And Tracheal Prostheses - Guidance For Industry | PDF (52.1 KB) | Premarket, Medical Devices | Final | 04/28/1998 | |
| 229 | 二类设备免于上市前通知的程序，行业和CDRH工作人员的指导 | Procedures for Class II Device Exemptions from Premarket Notification, Guidance for Industry and CDRH Staff | PDF (20.6 KB) | Premarket, Medical Devices, Radiation-Emitting Products | Final | 02/19/1998 | |
| 230 | 便利工具包临时监管指导 | Convenience Kits Interim Regulatory Guidance | PDF (31.23 KB) | Premarket, Medical Devices | Final | 05/20/1997 | |
| 231 | 非侵入性血压（NIBP）监测仪指南 | Non-Invasive Blood Pressure (NIBP) Monitor Guidance | FDA-2020-D-0957 | Premarket, Medical Devices | Final | 03/10/1997 | |
| 232 | 510(K) 信息需要用于羟基磷灰石涂层骨科植入物 | 510(K) Information Needed for Hydroxyapatite Coated Orthopedic Implants | FDA-2020-D-0957 | Premarket, Medical Devices | Final | 02/20/1997 | |
| 233 | 第三方评审指导：玻璃体抽吸和切割设备上市前通知（510(k)） | Third Party Review Guidance For Vitreous Aspiration and Cutting Device Premarket Notification (510(k)) | FDA-2020-D-0957 | Premarket, Medical Devices | Final | 01/31/1997 | |
| 234 | 口交中用于性病防护的屏障装置潜在制造商 | Prospective Manufacturers of Barrier Devices Used During Oral Sex for STD Protection | PDF (79.74 KB) | Medical Devices | Final | 10/31/1996 | |
| 235 | 发射激光束作为II类和IIIa类激光产品的发射指示器（激光通知49） | Emitted Laser Beam as Emission Indicator for Class II and Class IIIa Laser Products (Laser Notice 49) | PDF (58.9 KB) | Medical Devices, Radiation-Emitting Products | Final | 09/05/1996 | |
| 236 | 制造商报告编号格式的变更 - 第5号 | Variance from Manufacturer Report Number Format - No. 5 | FDA-2020-D-0957 | Postmarket, Medical Devices | Final | 08/12/1996 | |
| 237 | 激光投影的有效视觉控制（激光通知47） | Effective Visual Control of Laser Projections (Laser Notice 47) | PDF (147.45 KB) | Medical Devices, Radiation-Emitting Products, Radiological Health | Final | 06/06/1996 | |
| 238 | 医疗器械用户设施报告 | Medical Device Reporting for User Facilities | PDF (313.13 KB) | Medical Devices, Radiation-Emitting Products, Radiological Health | Final | 04/01/1996 | |
| 239 | 宫腔镜和妇科腹腔镜 - 510(k) 提交指南 | Hysteroscopes and Gynecology Laparoscopes - Submission Guidance for a 510(k) | PDF (1.15 MB) | Premarket, 510(k), Medical Devices | Final | 03/07/1996 | |
| 240 | 对医疗机构使用的灭菌器的上市前通知[510(k)]提交指南的附录 | Addendum to: Guidance on Premarket Notification [510(k)] Submissions for Sterilizers Intended for Use in Health Care Facilities | FDA-2020-D-0957 | Premarket, Medical Devices | Final | 09/19/1995 | |
| 241 | 宫腔镜和腹腔镜气体膨胀器：510(k)提交指南 | Hysteroscopic and Laparoscopic Insufflators: Submission Guidance for a 510(k) | FDA-2020-D-0957 | Premarket, Medical Devices | Final | 08/01/1995 | |
| 242 | 加热和冷却设备预市场通知[510(k)]申请准备指导文件 | Guidance Document for the Preparation of Premarket Notification [510(k)] Applications for Heating and Cooling Devices | PDF (14.05 KB) | Premarket, Medical Devices | Final | 07/26/1995 | |
| 243 | 新材料（非乳胶）男性安全套测试指导 | Testing Guidance for Male Condoms Made From New Material (Non-Latex) | FDA-2020-D-0957 | Premarket, Medical Devices | Final | 06/29/1995 | |
| 244 | 医疗激光的上市前通知内容和组织指导 | Guidance on the Content and Organization of a Premarket Notification for a Medical Laser | PDF (71.58 KB) | Premarket, Medical Devices, Radiation-Emitting Products, Radiology | Final | 06/01/1995 | |
| 245 | CPG第300.300节 无效设备 - 502(f)(I) 标签要求 | CPG Sec. 300.300 Ineffective Devices - 502(f)(I) Labeling Requirements | FDA-2020-D-0957 | Investigation & Enforcement, Labeling, Medical Devices | Final | 03/01/1995 | |
| 246 | CPG第310.100节 心脏起搏器再利用 | CPG Sec. 310.100 Pacemaker Reuse | FDA-2020-D-0957 | Investigation & Enforcement, Cardiovascular , Medical Devices | Final | 03/01/1995 | |
| 247 | CPG第345.300节 月经海绵 | CPG Sec. 345.300 Menstrual Sponges | FDA-2020-D-0957 | Investigation & Enforcement, Medical Devices, Physical Medicine | Final | 03/01/1995 | |
| 248 | CPG第355.300节 离子生成设备 | CPG Sec. 355.300 Ion Generating Devices | FDA-2020-D-0957 | Investigation & Enforcement, Medical Devices, Radiation-Emitting Products, Radiological Health | Final | 03/01/1995 | |
| 249 | CPG第390.425条 记录和报告；适用性 - 21 CFR 1002.1 | CPG Sec. 390.425 Records and Reports; Applicability - 21 CFR 1002.1 | FDA-2020-D-0957 | Investigation & Enforcement, Medical Devices, Radiation-Emitting Products, Records | Final | 03/01/1995 | |
| 250 | CPG第398.200节 危险诊断X射线系统 | CPG Sec. 398.200 Hazardous Diagnostic X-ray Systems | FDA-2020-D-0957 | Investigation & Enforcement, Medical Devices, Radiation-Emitting Products, Radiology | Final | 03/01/1995 | |
| 251 | 陶瓷球髋关节系统预市场通知准备指导文件 | Guidance Document For The Preparation of Premarket Notification For Ceramic Ball Hip Systems | PDF (36.84 KB) | Premarket, Medical Devices | Final | 01/10/1995 | |
| 252 | 510(k) 无菌润滑凝胶与经尿道外科器械使用的检查清单 | 510(k) Checklist for Sterile Lubricating Jelly Used With Transurethral Surgical Instruments | FDA-2020-D-0957 | Premarket, Medical Devices | Final | 09/19/1994 | |
| 253 | 扩展腹腔镜设备（ELD）预市场通知准备指南 | Guidance for the Preparation of a Premarket Notification for Extended Laparoscopy Devices (ELD) | PDF (11.56 KB) | Premarket, Medical Devices | Final | 08/30/1994 | |
| 254 | 尿液引流袋上市前通知内容指南 | Guidance for the Content of Premarket Notifications for Urine Drainage Bags | PDF (500.32 KB) | Premarket, 510(k), Medical Devices | Final | 06/07/1994 | |
| 255 | 信函 - 避孕套产品的制造商、分销商和进口商（包含在避孕套包装398中）：信函 - 避孕套产品的制造商、分销商和进口商 | Letter - Manufacturers, Distributors and Importers of Condom Products (included in Condom Packet 398) : Letter - Manufacturers, Distributors and Importers of Condom Products | PDF (74.51 KB) | Postmarket, Premarket, Medical Devices | Final | 02/23/1994 | |
| 256 | 关于锐器容器预市场通知[510(k)]提交内容和格式的指导 | Guidance on the Content and Format of Premarket Notification [510(k)] Submissions for Sharps Containers | PDF (296.78 KB) | Premarket, 510(k), Medical Devices | Final | 10/01/1993 | |
| 257 | 关于用于医疗机构的自动内窥镜清洗机、清洗/消毒机和消毒机的上市前通知[510(k)]提交指南 | Guidance on Premarket Notification [510(k)] Submissions for Automated Endoscope Washers, Washer/Disinfectors, and Disinfectors Intended for Use in Health Care Facilities | PDF (954.92 KB) | Premarket, 510(k), Medical Devices | Final | 08/01/1993 | |
| 258 | 激光系统II类和IIIa类的光束衰减器和发射指示器（激光通知43） | Beam Attenuators and Emission Indicators for Class II and IIIa Laser Systems (Laser Notice 43) | PDF (90.36 KB) | Medical Devices, Radiation-Emitting Products, Radiological Health | Final | 06/07/1993 | |
| 259 | 关于皮下注射单腔针预市场通知[510(K)]提交内容的指导 | Guidance on the Content of Premarket Notification [510(K)] Submissions for Hypodermic Single Lumen Needles | FDA-2020-D-0957 | Premarket, 510(k), Medical Devices | Final | 04/01/1993 | |
| 260 | 医疗机构使用的灭菌器预市场通知510(k)指南 | Guidance on Premarket Notification 510(k) for Sterilizers Intended for Use in Health Care Facilities | PDF (843.41 KB) | Premarket, 510(k), Medical Devices | Final | 03/01/1993 | |
| 261 | 胃肠病学和泌尿学中使用的活检设备的上市前通知内容指南 | Guidance for the Content of Premarket Notifications for Biopsy Devices Used in Gastroenterology and Urology | FDA-2020-D-0957 | Premarket, Medical Devices | Final | 02/10/1993 | |
| 262 | 激光产品合规指南 (FDA 86-8260) | Compliance Guide for Laser Products (FDA 86-8260) | PDF (211.25 KB) | Medical Devices, Radiation-Emitting Products, Radiological Health | Final | 06/01/1992 | |
| 263 | CPG第335.800节 临床温度计 - 掺假；错误标记缺陷 | CPG Sec. 335.800 Clinical Thermometer - Adulteration; Misbranding Defects | PDF (64.91 KB) | Investigation & Enforcement, Administrative / Procedural, Medical Devices | Final | 05/31/1991 | |
| 264 | 设备标签指导 #G91-1 (蓝皮书备忘录) | Device Labeling Guidance #G91-1 (Blue Book Memo) | FDA-2020-D-0957 | Premarket, Labeling, Medical Devices | Final | 03/08/1991 | |
| 265 | 标记 - 医疗器械的监管要求 (FDA 89-4203) | Labeling - Regulatory Requirements for Medical Devices (FDA 89-4203) | PDF (2.98 MB) | Medical Devices | Final | 09/01/1989 | |
| 266 | 诊断X射线设备辐射控制规定的澄清（第一部分） | Clarification of Radiation Control Regulations for Diagnostic X-Ray Equipment (Part 1 ) | PDF (925.48 KB) | Medical Devices, Radiation-Emitting Products, Radiology | Final | 03/01/1989 | |
| 267 | 诊断X射线设备辐射控制规定的澄清（第三部分） | Clarification of Radiation Control Regulations for Diagnostic X-Ray Equipment (Part 3) | PDF (1.08 MB) | Medical Devices, Radiation-Emitting Products | Final | 03/01/1989 | |
| 268 | 建立和维护微波炉合规调查仪器校准一致性互比系统的指南（FDA 88-8264）(仅限PDF) | Guide for Establishing and Maintaining a Calibration Constancy Intercomparison System for Microwave Oven Compliance Survey Instruments (FDA 88-8264)] (PDF Only) | PDF (826.14 KB) | Medical Devices, Radiation-Emitting Products, Radiological Health | Final | 03/01/1988 | |
| 269 | CPG 第300.100节 设备组件制造商的检查 | CPG Sec. 300.100 Inspection of Manufacturers of Device Components | FDA-2020-D-0957 | Investigation & Enforcement, Medical Devices | Final | 09/24/1987 | |
| 270 | CPG第320.100节 耳洞穿刺设备 | CPG Sec. 320.100 Ear Piercing Devices | FDA-2020-D-0957 | Investigation & Enforcement, Medical Devices | Final | 09/24/1987 | |
| 271 | CPG第345.200节 膈膜 - 处方设备 | CPG Sec. 345.200 Diaphragms - Rx Devices | FDA-2020-D-0957 | Investigation & Enforcement, Labeling, Medical Devices | Final | 09/24/1987 | |
| 272 | 主文件第三部分 - 科学和技术信息指南 | Master Files Part III - Guidance on Scientific and Technical Information | PDF (317.65 KB) | Premarket, Medical Devices | Final | 06/01/1987 | |
| 273 | 走入工作站（激光通知37） | Walk-In Workstations (Laser Notice 37) | PDF (85.64 KB) | Medical Devices, Radiation-Emitting Products | Final | 10/21/1985 | |
| 274 | 医疗激光传输系统联锁装置（激光通知34） | Medical Laser Delivery System Interlocks (Laser Notice 34) | PDF (90.27 KB) | Medical Devices, Radiation-Emitting Products | Final | 01/20/1985 | |
| 275 | 某些日光灯产品制造商的报告和记录保存要求豁免 | Exemption from Reporting and Record keeping Requirements for Certain Sunlamp Product Manufacturers | PDF (74.01 KB) | Medical Devices, Radiation-Emitting Products | Final | 09/16/1981 | |
| 276 | CPG第390.100条 “商业”的定义 - 21 CFR 1000.3(d) 2 | CPG Sec 390.100 Definition of “Commerce” - 21 CFR 1000.3(d) 2 | PDF (16.41 KB) | Investigation & Enforcement, Medical Devices | Final | 10/01/1980 | |
| 277 | 符合联邦汞蒸气灯性能标准的质量控制实践 | Quality Control Practices for Compliance with the Federal Mercury Vapor Lamp Performance Standard | PDF (1.81 MB) | Medical Devices | Final | 05/01/1980 | |
| 278 | 免除能源部、国家海洋和大气管理局及美国商务部使用的某些激光（激光通知25） | Exemption of Certain Lasers Used By DOE, NOAA and U.S. Dept. of Commerce (Laser Notice 25) | PDF (116.62 KB) | Medical Devices, Radiation-Emitting Products, Radiological Health | Final | 09/14/1979 | |
| 279 | 宫腔镜绝育器评估指南 | Guidance ('Guidelines') for Evaluation of Hysteroscopic Sterilization Devices | PDF (19.79 KB) | Premarket, Medical Devices | Final | 05/10/1978 | |
| 280 | 染料和多波长激光器的警告标签（激光通知16） | Warning Labels For Dye And Multiple Wavelength Lasers (Laser Notice 16) | PDF (83.75 KB) | Medical Devices, Radiation-Emitting Products, Radiological Health | Final | 03/02/1977 | |
| 281 | 内部制造和使用的激光器（激光通知14） | Lasers Manufactured and Used In-House (Laser Notice 14) | PDF (54.95 KB) | Laser Notice, Medical Devices, Radiation-Emitting Products | Final | 11/23/1976 | |
| 282 | 远程联锁连接器（激光通知11） | Remote Interlock Connectors (Laser Notice 11) | PDF (62.34 KB) | Medical Devices, Radiation-Emitting Products | Final | 10/07/1976 | |
| 283 | 观察光学 - 瞄准望远镜（激光通知8） | Viewing Optics - Sighting Telescope (Laser Notice 8) | PDF (70.59 KB) | Medical Devices, Radiation-Emitting Products | Final | 08/05/1976 | |
| 284 | 根据21-CFR 1020.40提交柜式X射线系统报告的指南 | Guidance for the Submission of Cabinet X-Ray System Reports Pursuant to 21-CFR 1020.40 | PDF (651.51 KB) | Medical Devices, Radiation-Emitting Products, Radiological Health | Final | 02/01/1975 | |
