M. Elizabeth BiermanMichele L. Buenafe
“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...
[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,械字号办理,MDL认证,TGA认...
870.2300 心律失常检测和报警器 21CFRDSIII 870.1025 心电诊断设备 21CFRDPSII 870.2340 体外自动除颤器 21CFRMKJIII 870.5310 心电治疗设备、侵入性设备 III 本幻灯的适用 •本幻灯适用于心律失常检测和报警器的FDA申请•本幻灯根据GuidanceforIndustryandFDAStaff -ClassIISpecialControlsGuidanceDocument:Arrhythmia...
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...
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 ...
* * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * 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...
Biocompatibility ISO 10993 510 K Guidance recommends testing to ISO 10993 Sampling ANSI/ASQC Z1.4 ISO 2859-1 1. AQL 4% for BFE,PFE, Delta P 2. 32 masks for Synthetic Blood (Pass=≥29 passing, Fail=≤28 passing) 3. 14 masks for Flammability <5.0 mmh2o=""><6.0.<><5.0 ...
Guidance on the CDRH Premarket Notification Review Program 6/30/86 (K86-3)16 此节要求仪器等效比需要另外再单独描述, ,要注意把关键的参数进行比对描述, 如光功率密度,存储环境,输出波形,脉冲宽度,电压等.,如何准备510K 申请文件,FDA 510K Screen checklist 要求的申请文档或报告(8): Biocompatibility 生物...
Vuze Medical, based in Ra'anana, Israel, is a privately-held medical technology company that aims to provide highly accurate and cost-effective surgical guidance for common skeletal interventions currently aided only by standard 2D X-Ray, with a current focus on spine. The compa...