原文网址：https://mp.weixin.qq.com/s/q_6kKSDtUyi-bziQCFwPNQ

美国食品和药物管理局 （FDA） 每月都会发布MedSun月度通讯以告知患者和患者倡导者有关各种主题的 FDA 相关信息，包括 FDA 已授权上市的新产品、重大标签更改、安全警告、即将举行的公开会议通知、拟议的监管指南和评论机会，以及患者和患者倡导者感兴趣的其他信息。

本期，捷闻为大家整理了MedSun计划中发布的2023年全年美国FDA指导文件的决案及草案，附上相关链接供大家参考，欢迎查阅！

● 评估医疗器械提交中计算建模和仿真的可信度

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/assessing-credibility-computational-modeling-and-simulation-medical-device-submissions?utm_medium=email&utm_source=govdelivery

● 临床调查中远程数据采集的数字卫生技术

https://www.federalregister.gov/documents/2023/12/22/2023-28262/digital-health-technologies-for-remote-data-acquisition-in-clinical-investigations-guidance-for?utm_medium=email&utm_source=govdelivery

● 评估医疗器械提交中计算建模和仿真的可信度

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/assessing-credibility-computational-modeling-and-simulation-medical-device-submissions?utm_medium=email&utm_source=govdelivery

● 临床电子体温计的执行政策

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/enforcement-policy-clinical-electronic-thermometers?utm_medium=email&utm_source=govdelivery

● 通知FDA根据FD&C法案第506J条永久停止或中断生产设备

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/notifying-fda-permanent-discontinuance-or-interruption-manufacturing-device-under-section-506j-fdc?utm_medium=email&utm_source=govdelivery

● 提交磁共振诊断设备上市前通知

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/submission-premarket-notifications-magnetic-resonance-diagnostic-devices?utm_medium=email&utm_source=govdelivery

● 磁共振(MR)环境中医疗器械的安全测试和标签

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/testing-and-labeling-medical-devices-safety-magnetic-resonance-mr-environment?utm_medium=email&utm_source=govdelivery

● 用于支持患者监护的非侵入式远程监护设备的执行策略

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/enforcement-policy-non-invasive-remote-monitoring-devices-used-support-patient-monitoring?utm_medium=email&utm_source=govdelivery

● 医疗器械中的网络安全:质量体系考虑和上市前提交的内容

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/cybersecurity-medical-devices-quality-system-considerations-and-content-premarket-submissions?utm_medium=email&utm_source=govdelivery

● 国际标准ISO 10993-1“医疗器械的生物学评价-第1部分:风险管理过程中的评价和试验”的使用

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/use-international-standard-iso-10993-1-biological-evaluation-medical-devices-part-1-evaluation-and?utm_medium=email&utm_source=govdelivery

● 促进医疗器械改进:FDA活动和参与自愿改进计划

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/fostering-medical-device-improvement-fda-activities-and-engagement-voluntary-improvement-program?utm_medium=email&utm_source=govdelivery

● 抗菌素敏感性试验(AST)系统设备-更新设备标签中的断点

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/antimicrobial-susceptibility-test-ast-system-devices-updating-breakpoints-device-labeling?utm_medium=email&utm_source=govdelivery

● 采用生理闭环控制技术的医疗器械的技术考虑

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/technical-considerations-medical-devices-physiologic-closed-loop-control-technology?utm_medium=email&utm_source=govdelivery

● 灾害和突发公共卫生事件对医疗产品临床试验的影响

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/considerations-conduct-clinical-trials-medical-products-during-major-disruptions-due-disasters-and?utm_medium=email&utm_source=govdelivery

● 临床研究者和申办者的知情同意指南

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/informed-consent?utm_medium=email&utm_source=govdelivery

● 医疗器械开发工具的资格:行业、工具开发人员和食品药品监督管理人员指南

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/qualification-medical-device-development-tools?utm_medium=email&utm_source=govdelivery

● 器械软件功能上市前提交的内容

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/content-premarket-submissions-device-software-functions?utm_medium=email&utm_source=govdelivery

● 与某些体外诊断测试一起使用的肿瘤药物产品:试点计划

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/oncology-drug-products-used-certain-in-vitro-diagnostic-tests-pilot-program?utm_medium=email&utm_source=govdelivery

● 电力粉碎过程中使用的组织密封系统的非临床性能评估

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/non-clinical-performance-assessment-tissue-containment-systems-used-during-power-morcellation?utm_medium=email&utm_source=govdelivery

● 全切片成像在非临床毒理学研究中的应用:问题与答案

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/use-whole-slide-imaging-nonclinical-toxicology-studies-questions-and-answers?utm_medium=email&utm_source=govdelivery

● 外周经皮腔内血管成形术(PTA)和特种导管-上市前通知(510(k))提交

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/peripheral-percutaneous-transluminal-angioplasty-pta-and-specialty-catheters-premarket-notification?utm_medium=email&utm_source=govdelivery

● 使用真实世界证据来支持医疗器械的监管决策

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/draft-use-real-world-evidence-support-regulatory-decision-making-medical-devices?utm_medium=email&utm_source=govdelivery

● 选择506J指南的更新:506J设备列表和其他通知

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/select-updates-506j-guidance-506j-device-list-and-additional-notifications?utm_medium=email&utm_source=govdelivery

● 从公司到医疗保健提供者关于已批准/已批准医疗产品未经批准使用的科学信息的沟通问答

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/communications-firms-health-care-providers-regarding-scientific-information-unapproved-uses?utm_medium=email&utm_source=govdelivery

● 与减肥相关的适应症医疗器械。临床研究和获益-风险考虑

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/medical-devices-indications-associated-weight-loss-clinical-study-and-benefit-risk-considerations?utm_medium=email&utm_source=govdelivery

● 上市后研究和临床试验:确定不符合《联邦食品、药品和化妆品法》第505(o)(3)(E)(ii)条的正当理由

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/postmarketing-studies-and-clinical-trials-determining-good-cause-noncompliance-section-505o3eii?utm_medium=email&utm_source=govdelivery

● 用于治疗阿片类药物使用障碍的器械研究的临床考虑

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/clinical-considerations-studies-devices-intended-treat-opioid-use-disorder?utm_medium=email&utm_source=govdelivery

● 良好临床规范(GCP)

https://www.fda.gov/media/169090/download?utm_medium=email&utm_source=govdelivery

● 骨科植入物患者匹配指南

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/patient-matched-guides-orthopedic-implants?utm_medium=email&utm_source=govdelivery

● 药物、生物制品和器械的分散临床试验

https://www.fda.gov/media/167696/download?utm_medium=email&utm_source=govdelivery

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