FDA注册(认证)是参与美国使用的医疗器械生产和分销的业务场所(也称为机构或设施)的业主或经营者在产品正式上市销售前向FDA(美国食品药品监督管理局)提交电子登记的过程。医疗器械FDA注册分为:FDA企业注册(Facility Registration)和器械列名(Medical Device Listings)两部分。 器械商用英文名称(附产品说明) 产品代码、标签...
DFUF账号/密码（Device Facility User Fee website）FURLS账号/密码（FDA’s Unified Registration and Listing System）方法/步骤 1 FDA器械分类查询：根据器械性能、用途判断其分类，通过风险分类确认查询器械代码 2 FDA企业行政美金缴纳：创建DFUF账户，申请PINs，支付该年度行政年金，获得PCNs 3 FDA企业信息登记：创...
第1页 Registration inquiry website: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm FDA Fiscal Year 2024 This is a notice to the establishment whose Facility Registration and Device Listing have been done within the Fiscal Year 2024. Establishment information Name: JIANGSU YISHUN ...
the company has 30 days to register the facility and list each device with the FDA. Before registering with the FDA, you must also make a second DFUF payment for the establishment registration fee of $9,280
FDA charges an annual Device Facility User Fee each year upon renewal. While facility registration is an important part of manufacturing and distributing medical device products, there are other regulatory requirements for companies to follow as well. Visit ourMedical Devices pagefor more information....
• Displaying a “Certificate of FDA Facility Registration and Device Listing of Medical Device” issued by “HUMISS INC.” (HUMISS Certificate) under the “Company qualification” heading, “Product” tab on the product’s webpage. The HUMISS Certificate states that “Dongguan City Xinyuan Non...
FDA FacilityRegistration and Device Listing Application Form For FOOD FDA食品企业注册及产品列名申请表 Applicantinformation Company Name公司名称 Company Address地址 Post Code邮编 Contact person (Full name)联系人(全名) Tel电话 Fax传真 Mail邮箱 Website网站 ...
在FDA设备注册和设施清单(Device Registration and Facility Listing)系统中注册您的产品和生产设施。 提交510(k): 使用FDA电子提交门户提交510(k)申请,确保遵循FDA的要求和格式。 等待FDA审查: 等待FDA对您的510(k)申请进行审查。审查时间可能因产品复杂性和FDA工作负荷而有所不同。
此外，特定食品品牌的备案信息可以通过“Food Facility Registration and Listing System”（FURLS）进行查询...
FDA’s rationale: Obtaining facility registration and device listing information may help FDA to obtain an initial understanding of the universe of IVDs offered as LDTs to help the agency prepare for premarket review of such tests. FDA also indicates that requiring compliance with...