FDA510K医疗器械范围,如电子血压计,电子体温计、雾化器、ECG心电图仪、电动轮椅、肌肉刺激仪、微导管导丝产品等注册FDA510K,需要准备所有提交报告的文档报告要求工厂按照要求的各部分文档信息提交相应的报告,为了工厂更详细了解对于某种特定的产品要申请FDA510K的测试报告以及文档要求,FDA了一些详细的Guidance,即510K指南。
FDA提供了一些详细的Guidance,即510K指南。 轮椅FDA 510K认证流程 1. 确定申请信息清单:根据客户产品及FDA相关法规,确定指导原则510(k)申请信息清单。 清单包含编写510(k)申请文件所需的所有材料及要求,例如图纸、规格、原材料、测试项目及测试方案(如有)等。 2. 选定对比产品:根据客户提供的初步材料(如说明书、产...
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...
2.510(k) Cover Letter* 旨在简单的描述 510(k)提交申请的信息,如提交者,510(k)申请路径,产品分类和预期用途等等。这份文件有助于FDA对资料的初步处理和审查。Guidance 有专门附录建议了Cover letter 需要包含的关键信息。 3.Truthful and Accuracy Statement* 是510(k)申请必须包含的文件,对于这个文件 FDA有提供...
The draft guidance was also revised to reflect the new name of the pathway as this had been previously dubbed the “Expanded Abbreviated 510(k) program.” Experts have argued, however, that the language FDA has applied throughout the debate wro...
根据FDA发布的有关简化510(k)的指南文件“The Abbreviated 510(k) Program: Guidance for Industry and Food and Drug Administration Staff”，器械制造商的申请如果依据以下一项或多项内容，可选择简化510(k)项目：• FDA指南文件；• 器械特定分类法规或某一器械类型的特殊控制指南的符合性证明；和/或• ...
FDA提供了一些详细的Guidance,即510K指南。 轮椅FDA 510K认证流程 1. 确定申请信息清单:根据客户产品及FDA相关法规,确定指导原则510(k)申请信息清单。 清单包含编写510(k)申请文件所需的所有材料及要求,例如图纸、规格、原材料、测试项目及测试方案(如有)等。 2. 选定对比产品:根据客户提供的初步材料(如说明书、...
standards and guidance documents. Your medical device or IVD might qualify for this type of submission submission if: special controls have been established, you have followed FDA Recognized Consensus Standards, FDA guidance documention exists. ISOplan can assist your company preparing a successful ...
美国FDA 指导原则 牙科手机上市前通知[510(K)]行业和FDA员工提交指南 英文原版 Guidance for Industry and FDA Staff Dental Handpieces - Premarket Notification [510(k)] Submissions Document issued on: May 2, 2007 This guidance supersedes “Guidance Document on Dental Handpieces”issued July 1995 For...
1. U.S. Food and Drug Administration. (2021). Device Advice:Comprehensive Regulatory Assistance. Retrieved fromhttps://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/default.htm 2. U.S. Food and Drug Administration. (2021). PremarketNotification 510(k). Retrieved from...