FDA-510K所需准备的文件.pdf

序号 Title 文件名 Related Information Medical Device User Fee Cover 1 缴费证明文件 Medical Device User Fee Cover Sheet Sheet (Form FDA 3601) CDRH Premarket Review Submission 2 CDRH Premarket Review Submission Cover Sheet Cover Sheet CDRH上市前审核提交表格 Appendix A of Guidance for Industry and FDA Staff Format for 3 510(k) Cover Letter 510k封面信件 Traditional and Abbreviated 510(k)s Indications for Use Statement 4 预期用途 Indications for Use Statement 5 510(k) Summary or 510(k) Statement 510k总结或510k声明 510(k) Summary or 510(k) Statement Truthful and Accuracy Statement 6 真实与准确性声明 Truthful and Accuracy Statement Class III Summary and Certification 7 III类总结和声明 III类设备所需准备的 Financial Certification or Certification 8 财务证明或应行公告的财务事项 Disclosure Statement Disclosure Declarations of Conformity and 9 Summary Reports (Abbreviated 一致性声明和总结报告 （简要510k） 该文件适合510k提交方式为简要510k 510(k)s) 10 Executive Summary 执行总结 11 Device Description 设备说明 12 Substantial Equivalence Discu