https://www.fda.gov/medical-devices/device-registration-and-listing/access-electronic-registration https://www.access.fda.gov/oaa/logonFlow.htm?execution=e1s1 (对于以上四点,也可以参看FDA 网页介绍 How to Register and List) (https://www.fda.gov/medical-devices/device-registration-and-listing/how...
https://www.fda.gov/medical-devices/device-registration-and-listing/access-electronic-registration https://www.access.fda.gov/oaa/logonFlow.htm?execution=e1s1 (对于以上四点,也可以参看FDA 网页介绍 How to Register and List) (https://www.fda.gov...
（1）FDA与NMPA均将医疗器械划分为Ⅰ、Ⅱ、Ⅲ三类，其中FDA主要是根据其潜在风险程度进行分级，而NMPA除...
注册第一步是要判断您的产品是否是属于美国FDA管辖下的产品，如果是，是具体的哪一个分类Product Code。
http://www.fda.gov/medical-devices 七,510(k)申请流程 确定产品代码(Product Code):大约需要1个工作日。不同类别的产品通常有不同的产品代码。确定比对产品:确定具体上市产品作为比对器械,通常需要3-5个工作日。比对器械需要与申请的产品属于同类或非常相似。确定测试标准并进行测试:相关的测试报告需要进行测试,这...
https://www.fda.gov/medical-devices/device-registration-and-listing/access-electronic-registration 比如,玻璃体切割产品。 首先属于,眼科产品,对应到21 CFR 886中。进而对应到886.4150。发现是II类,Special Control。 使用Product Classification数据库查询886.4150。
Some examples of baseline characteristics for vaccine studies include, but are not limited to, past medical history (e.g., prior infection history), immunosuppressive conditions, prior vaccination history and concomitant medications/vaccines.受试者级分析数据 (ADSL) 是 ADaM 的受试者级分析数据集。所有...
26 药品良好制造规范报告、医疗器械质量体系核查报告以及某些医疗器械产品评价报告的互认:美国与欧共体 MUTUAL RECOGNITION OF PHARMACEUTICAL GOOD MANUFACTURING PRACTICE REPORTS, MEDICAL DEVICE QUALITY SYSTEM AUDIT REPORTS, AND CERTAIN MEDICAL DEVICE PRODUCT EVALUATION REPORTS: UNITED STATES AND THE EUROPEAN COMMUNITY...
Here's how we will approach your medical device 510(k) application: Confirm your FDA product code, regulation number, and predicate devices. This is crucial. If the wrong product code is chosen, it can lead to rejection of your FDA 510(k) application and months of lost commercial sales....
报告D Report D:可疑医疗器械SUSPECT MEDICAL DEVICE D1:商标名称Brand Name D2:设备类型Type of Device (设备通用名称Common Device Name 、产品代码Product code ) D3:制造商Manufacturer (名称Name、邮箱Email Address、地址Address、电话Phone Numbers)