(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-register-and-list) 5.资料提交(电子) https://www.fda.gov/medical-devices/how-study-and-market-your-device/ec...
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。
FDA列名(Establishment Registration & Device Listing):可以登录FDA官网的设备列名查询页面,在该页面上输入相关信息进行搜索,以确认产品是否已经进行了列名。 Establishment Registration & Device http://Listingwww.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm 510K注册(510(k) Premarket Notification):可以登录...
具体的操作步骤详见How to Register and List (https://www.fda.gov/medical-devices/device-registration-and-listing/how-register-and-list) 3. De Novo 新型医疗器械分类 在美国,对于没有合法上市对比产品的器械,即使属于中低风险,仍然无法通过510k,申请途径建立实质等同,从而获得上市许可。针对这类产品,FDA于建...
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...
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。
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...
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)
The goal for CDRH was to review 100% of the medical devices subject to a premarket approval applications (PMAs) approved prior to 2010 to determine, for each product code, whether or not to reduce premarket data coll...
list of officers and directors to fect an approved exemption for inves- the Food and Drug Administration tigational use under section 520(g) of upon the request of the Commissioner; the act and part 812 of this chapter; and (3) Any distribution of a device, be- (4) The receipt of ...