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...
FDA Issues Draft Guidance on 510(k) Device Modifications: New Emphasis on Potential Impact of ModificationsM. Elizabeth BiermanPhoebe Mounts, Ph.DMichele L. Buenafe
[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 成立日期 2012年03月31日 法定代表人 陈庆佳 注册资本 5000 主营产品 医疗器械FDA认证,医疗器械FDA注册,医疗器械CE认证,NMPA注册,械字...
“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...
“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 methods recommended in the guidances where feasibl...
4.FDA指导文件Guidancedocuments. 这个需要在FDA搜索了,比较耗时,FDA文件和指导规范特别多。 5. 软件或固件:Software or firmware.FDAZui近更改了验证软件或固件有效性的要求。软件或固件更新也会成为FDA比较关心的点,重大软件更新或固件更新可能需要提交新的510(K)审核。 6. 临床数据:510(K)并不要求临床数据,也有...
The FDA’s Center for Devices and Radiological Health (CDRH) released four final guidance documents on Thursday, Sept. 12, which provides the FDA’s current thinking on the Special 510(K) program, the Abbreviated 510(K) program, how to format Traditional and Abbrevia...
807.87(e).Generally, if the device is an in vitro diagnostic device, thelabeling must also satisfy the requirements of 21 CFR 809.10.Additionally, the term “labeling” generally includes the devicelabel, instructions for use, and any patient labeling. See“Guidance on MedicalDevice Patient ...
Resources 510k Submissions Software System | MasterControl 510(k) Guidance | MasterControl 510(k) FDA Database for Medical Devices Articles What 2019 Data Reveals About FDA’s 510(k) Program Related Terms Medical Device Quality Management System Annex 11 FDA QMSR See More Resources Let...
* * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * 5.如何確定設計變更是否會引發新的510k)申請 具體見《產品變更控制程式》,該程式是直接由FDA GUIDANCE轉換來的,主要由專案負責人組織工程師來確定設計變更是否會引發新的510(k)申請。 產品變更控制 評估...