FDA法律法规培训.pptVIP

FDA 法律法规培训 培训内容FDA 认证流程及认证文件企业注册，510（k） 与 产品列示510（k）Summary介绍510（K）查询及产品代码设计变更控制医疗器械法规监管产品labeling的法规符合性违规后的处罚及相关事宜关于产品进口到美国的信息 申请FDA所涉及的法规Code of Federal Regulations (CFR) Title 21 part 800-1299Food, Drug, and Cosmetic Act ( The FDC Act ) of 1938Food and Drug Administration Amendments Act of 2007 ( FDAAA )Medical Device User Fee and Modernization Act (MDUFMA) of 2002后两个法令是对The FDC Act 的修订,还有很多对该法令的修订，具体见/RegulatoryInformation/Legislation/FederalFoodDrugandCosmeticActFDCAct/SignificantAmendmentstotheFDCAct/default.htm ?1. FDA认证流程 FDA认证文件1 Medical Device User Fee Cover Sheet (Form FDA 3601)2 CDRH Premarket Review Submission Cover Sheet3 510(k) Cover Letter4 Indications for Use Statement5 510(k) Summary or 510(k) Statement6 Truthful and Accuracy Statement7 Financial Certification or Disclosure Statement FDA认证文件8Executive Summary9 Device Description10 Substantial Equivalence Discussion11 Proposed Labeling12 Sterilization and Shelf Life FDA认证文件13 Biocompatibility14 Software15 Electromagnetic Compatibility and Electrical Safety16 Performance Testing – Bench17 Performance Testing – Clinical 1 Medical Device User Fee Cover Sheet (Form FDA 3601) The Medical Device User Fee Cover Sheet and receipt of the user fee payment, allow FDA to begin processing your submission; therefore, you should provide a Medical Device User Fee Cover Sheet with your 510(k) submission。此文件是缴费的证明文件，缴费之后FD对提交的注册材料进行审核。FDA认证文件 2 CDRH Premarket Review Submission Cover Sheet CDRH(Center for device and radiological health 器械和放射健康中心) FDA-3514表格（5页）记录了510K的提交方式、公司的基本信息等等。FDA认证文件 FDA认证文件3. 510(k) Cover Letter此文件包含510K提交文件的一些信息：提交人的信息，设备的通用名称，提交方式，联系人信息，设备类型等等。FDA-3654表格记录了申请注册的医疗器械适用的标准，凡是此表中的标准，在提交文件中都附有标准的检测报告。 FDA认证文件4 Indications for Use Statement所申请的医疗器械的使用声明（预期用途）5 510(k) Summary or 510(k) Statement我公司一般使用510（k）Summary,提供产品通用名、商品名、选择已经合法上市的实质性等同的器械、申请注册的器械的描述以及性能描述等信息。 FDA认证文件6 Truthful and Accuracy Statement此文件是一份声明，证明提交的文件是真实准确的，并且没有遗漏任何文件。7 Financial Certification or Disclosure StatementFDA-375