The final guidance “expands the concept of the Abbreviated 510(k) program by explaining how substantial equivalence for certain device types may be demonstrated in a way that is less burdensome, but at least as robust,” FDA said. “Use of ...
510(k) Program, Companion Dx Among Top FDA Guidance Priorities For FY 2014Rebecca Kern
https://www.fda.gov/medical-devices/premarket-submissions/premarket-notification-510k United State Food and Drug Administration (US FDA). The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510K)]. Guidance for Industry and Food and Drug Administration Staff. [Published ...
参照 FDA 官方指南（如《Compliance Program Guidance Manual》）编写 AOC，明确引用法规条款（例：“本产品符合 21 CFR Part 820 质量管理体系要求”）；确保文件包含制造商公章、授权人签字及日期，若通过第三方机构审核，可附认证报告。分类处理：器械类别AOC 重点要求 Class I（低风险）声明符合一般 controls（如标...
l常规Foley导管(https://www.fda.gov/regulatory-information/search-fda-guidance-documents/conventional-foley-catheters-performance-criteria-safety-and-performance-based-pathway) FDA将继续发布草案和终版的指导原则,以将该“基于安全和性能的途径”...
[1] The510(k) Program: Evaluating Substantial Equivalence in PremarketNotifications [510(k)] [2] Guidancefor Industry on General/Specific Intended Use 所属分类:中国商务服务网/其他认证服务 关于国瑞中安集团-实验室商铺首页|更多产品|联系方式|黄页介绍 ...
(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; ...
原文链接:https://www.fda.gov/regulatory-information/search-fda-guidance-documents/orthopedic-fracture-fixation-plates-performance-criteria-safety-and-performance-based-pathway I. 引言 本指南提供了骨折固定板的性能标准,以支持基于安全和性能的途径。[1]在此框架下,计划通过骨折固定板的基于安全和性能的途径申请...
then a special 510k is not an option. If there is no recognized standard for the device type and the FDA has not issued the guidance of a special control for your device classification, then an abbreviated submission is also not an option. A traditional 510k submission is your only option ...
两个费用,年年递增,需要申请美国FDA医疗器械产品注册和备案和朋友,请联系深圳市思博达彭先生或登录公司网站www.bccgd.com。 赠送510K电子递交申报格式部分内容供参考,更多更详细的请联系深圳市思博达彭先生或登录公司网站www.bccgd.com。 Structure of the current eSTAR 510(k) ElectronicSubmission Template ...