植入心脏起搏器的这个也有Guidance。 对于有Device-Specific Guidance的产品,应该满足Guidance的相关要求,否则可能在受理的时候被Refuse To Accept - RTA。 (第6点的相关内容,也可以参考FDA 网页介绍 How to Study and Market Your Device) (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory...
2FDA指南文件数据库Search for FDA Guidance Documents根据FDA《良好指南制定规范》，“指南”是指为FDA员工，注册申请人和公众准备的，用来描述FDA就某个法规议题所作出解释或指导的文件。在这个数据库中，用户可以随时检索到CDRH发出的医疗器械相关指南。3企业注册和设备列名数据库Establishment Registration & Device List...
FDA指南文件数据库 Search for FDA Guidance Documents | FDA 根据FDA《良好指南制定规范》,“指南”是指为FDA员工,注册申请人和公众准备的,用来描述FDA就某个法规议题所作出解释或指导的文件。在这个数据库中,用户可以随时检索到FDA的CDRH部门发出的医疗器械相关的指南。 03 企业注册和设备列表数据库 Establishment Re...
植入心脏起搏器的这个也有Guidance。 对于有Device-Specific Guidance的产品,应该满足Guidance的相关要求,否则可能在受理的时候被Refuse To Accept - RTA。 (第6点的相关内容,也可以参考FDA 网页介绍 How to Study and Market Your Device) (https://www.fda.gov...
审评指南数据库https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/guidance-documents-medical-devices-and-radiation-emitting-products FDA账号注册与登录https://www.access.fda.gov/oaa/logonFlow.htm?execution=e1s1
Software Contained in Medical Devices” (/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/u cm089543.htm) and “Guidance to Industry: Cybersecurity for Networked Medical Devices Containing Off-the-Shelf (OTS) Software” (/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/u cm077812....
3. FDA药物注册指南网站(CDER Guidance Documents):https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs 这个网站提供了关于药物注册的指南文件,包括注册要求、流程和相关政策。 4. FDA医疗器械注册网站(CDRH Medical Device Registration and Listing):https://www.fda.gov/medical-...
FDA指导文件-医疗设备中现成软件的使用Off-The-Shelf-Guidance_0.pdf,Contains Nonbinding Recommendations Off-The-Shelf Software Use in Medical Devices Guidance for Industry and Food and Drug Administration Staff Document issued on August 11, 2023. Document o
FDA Issues Final Guidance Documents on Medical Device Data Systems and Mobile Medical ApplicationsKeith A. Barritt
Guidance Documents (Medical Devices and Radiation-Emitting Products) - Draft Guidance for Industry and FDA Staff: Class II Special Controls Guidance Docume... Guidance Documents (Medical Devices and Radiation-Emitting Products) - Draft Guidance for Industry and FDA Staff: Class II Special Controls ...