美国时间2023年9月7日，FDA发布三份面向公众征求意见的草案，旨在对FDA 510（K）的申报进行现代化改造。三份草案分别为：1.Best Practices for Selecting a Predicate Device to Support a Premarket Notification [510(k)] Submission: Draft Guidance for Industry and Food and Drug Administration Staff（选择支持...
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...
510(k)申请是通过eSTAR或eCopy系统提交资料:eCopy模块的下载地址:https://www.fda.gov/medical-devices/how-study-and-market-your-device/ecopy-medical-device-submissions#:~:text=Starting%20October%201%2C%202023%2C%20all%20510%20%28k%29%20submissions%2C,electronic%20copy%20is%20not%20considered...
The US Food and Drug Administration has published new guidance updating its 510(k) Third Party Review program to align with the Medical Device Single Audit Program (MDSAP) launching in 2017. Besides identifying which elements of MDSAP will be added to the Third Party Review program, the draft ...
那么接下来主要是以传统510(k)申请文件目录来跟大家分享一下各个文件编制时需要注意的细节。 传统510(k)申请文件目录如下: (1) Medical Device User Fee Cover Sheet (Form FDA 3601) (2) Premarket Review Submission Cover Sheet (Form FDA 3514)
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...
提交资料:eCopy模块的下载地址:https://www.fda.gov/medical-devices/how-study-and-market-your-device/ecopy-medical-device-submissions#:~:text=Starting%20October%201%2C%202023%2C%20all%20510%20%28k%29%20submissions%2C,electronic%20copy%20is%20not%20considered%20an%20electronic%20submission....
Guidance for Industry and FDA Staff Biological Indicator (BI) Premarket Notification [510(k)] Submissions Document issued on: October 4, 2007 The draft of this document was issued May 21, 2001 This document supersedes FDA Guide for Validation of Biological Indicator Incubation Time, January 1, 19...
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• ...
美国FDA认证中的510(K)指的是一项医疗器械市场准入评估程序。这种程序被用于评估市场上的新型医疗器械,以确保其安全和有效性,同时还要比较它们与现有市场医疗器械之间的不同之处。 具体来说,当企业开发出一种新型医疗器械时,若与市场上的现有医疗器械有相似之处,企业就可在进行一番测试后,向FDA提交510(K)认证申请...