A彩盒可以简单点。但是如果彩盒是零售包装，建议将UDI打在包装上。QFDA产品指南文件怎么查找?Ahttps://www.fda.gov/regulatory-information/search-fda-guidance-documents#guidancesearch可以通过这个网站进去直接查找FDA指南文件。Q符合性声明应该宣称符合哪些标准，10993系列和ASTM F1980,ASTM D4169可以吗？A适用标准依据...
l磁共振接收线圈(https://www.fda.gov/regulatory-information/search-fda-guidance-documents/magnetic-resonance-mr-receive-only-coil-performance-criteria-safety-and-performance-based-pathway) l用于记录的皮肤电极(https://www.fda.gov/regulatory...
原文见FDA指南文件https://www.fda.gov/regulatory-information/search-fda-guidance-documents/submission-and-review-sterility-information-premarket-notification-510k-submissions-devices-labeled 需要了解的是该指南的适用范围仅限于采用基于微生物灭活的行业最终灭菌工艺灭菌的无菌类器械的510(k)审查。FDA认为目前生产过...
在完成eSTAR的过程中,提交者可以将附件添加为非结构化数据,包括但不限于提交者认为与设备审查相关的文档、PDF、图像和视频。此外,eSTAR将提示您提供所需的任何文档。 原文可点击一下链接 ↓ https://www.fda.gov/regulatory-information/search-fda-guidance-documents/electronic-submission-template-medical-device-510...
在不久的将来,正式版指南的出台,将更加有利于医疗器械制造商在510(k)申请过程中更加有针对性、有效地开展注册工作。 原文链接:https://www.fda.gov/regulatory-information/search-fda-guidance-documents/best-practices-selecting-predicate-device-support-premarket-notification-510k-submission...
(AI) during the review of the 510k. In fact, during the RTA checklist review, FDA reviewers will often cite specific references to guidance documents if the company has not applied them. You will run across many “draft” guidance documents in the FDA database, some going as far back as...
“The FDA intends to maintain a list of device types appropriate for the Safety and Performance Base Pathway on this website, accompanied by the guidance documents that identify the performance criteria for each device type, as well as the testing...
(https://www.fda.gov/regulatory-information/search-fda-guidance-documents/safety-and-performance-based-pathway)。 哪些器械类型适用基于安全和性能的途径? 当FDA确定: (1)新器械有相同的适应症,其技术性能与进行实质等效比较的器械相比不会产生不同的安全有效性方面的问题,并且; ...
Abbreviated 510k Clearance Process This submission type relies on the use of summary reports which demonstrate your use of special controls or Declarations of Conformity to recognized standards and guidance documents. Your medical device or IVD might qualify for this type of submission submission if: ...
19、商/cdrh/devadvice/351.html上市后监督上市后监督l上市后研究用于监测批准上市后各种永久性植入物的不良事件/cdrh/devadvice/352.htmll器械跟踪患者离开医院后,用来跟踪永久性植入物/声明支持器械的制度/cdrh/devadvice/353.html510(k)器械建议器械建议/cdrh/devadvice/Guidance DocumentsOverview of RegulationsInve...