Recently-Approved Devices 510(k) Clearances PMA Approvals进入相应项,即可搜索查询 Recently-Approved Devices 510(k) Clearances PMA Approvals 国内正在注册的体外诊断试剂,在FDA上市的情况 https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Databases/default.htm 510k文件有些查询结果这里可以直接下载。
[9] 产品8 GORE TAG THORACIC BRANCH ENDOPROSTHESIS (TBE DEVICE) 详细介绍原文 https://www.fda.gov/medical-devices/recently-approved-devices/gore-tag-thoracic-branch-endoprosthesis-p210032 [10] 产品9 LUMIPULSE G ß-AMYLOID RATIO (1-42/1-40) 详细介绍原文 https://www.fda.gov/news-events/pres...
3.Benjamens, S., P. Dhunnoo, and B. Mesko,The state of artificial intelligence-based FDA-approved medical devices andalgorithms: an online database. NPJ Digit Med, 2020. 3: p. 118. 4.https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-and-machine-lea...
Recently-Approved Devices 510(k) Clearances PMA Approvals 进入相应项,即可搜索查询 Recently-Approved Devices 510(k) Clearances PMA Approvals 国内正在注册的体外诊断试剂,在FDA上市的情况https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Databases/default.htm 510k文件有些查询结果这里可以直接下载。
[9] 产品8 GORE TAG THORACIC BRANCH ENDOPROSTHESIS (TBE DEVICE) 详细介绍原文 https://www.fda.gov/medical-devices/recently-approved-devices/gore-tag-thoracic-branch-endoprosthesis-p210032 [10] 产品9 LUMIPULSE G ß-AMYLOID RATIO (1-42/1-40) 详细介绍原文 ...
美国FDA 指导原则 用于用户设施的医疗设备报告 英文原版.pdf,Medical Device Reporting for User Facilities DEPARTMENT OF HEALTH AND HUMAN SERVICES Public Health Service Food and Drug Administration Medical Device Reporting for User Facilities Prepared by Off
FDA产品分类数据库网址: https://www.accessdata./scripts/cdrh/cfdocs/cfpcd/classification.cfm FDA“器械批准”网址: https://www./medical-devices/recently-approved-devices/2020-device-approvals
Getting Your Medical Device FDA Approved
D.UpdatingApprovedDrugProductSpecifications 更新已批准药品质量标准 APPENDIX:CASESTUDYEXAMPLESOFMICROBIOLOGICALCONTAMINATIONOFNSDPRODUCTS;IMPACTONPRODUCTQUALITYANDMANUFACTURINGPROCESS 附录:案例研究:NSD产品的微生物污染示例;对产品质量和生产工艺的影响 MicrobiologicalQualityConsiderationsinNon-sterileDrugManufacturingGuidancefor...
The goal for CDRH was to review 100% of the medical devices subject to a premarket approval applications (PMAs) approved prior to 2010 to determine, for each product code, whether or not to reduce premarket data col...