Indications for Use Statement (Form FDA 3881) 510(k) Summary or 510(k) Statement Truthful and Accuracy Statement Financial Certification or Disclosure Statement Declarations of Conformity and Summary Reports Device Description Executive Summary/Predicate Comparison Substantial Equivalence Discussion Proposed Lab...
Indications for Use– We recommend keeping this separate section of the device description. You should copy the content of FDA Form 3881 verbatim, or the reviewer will indicate that your submission is inconsistent. In the eSTAR, the indications for use can be automatically populated in the 510(k...
传统510(k)申请文件目录如下: (1) Medical Device User Fee Cover Sheet (Form FDA 3601) (2) Premarket Review Submission Cover Sheet (Form FDA 3514) (3) 510(k) Cover Letter (4) Indications for Use Statement (Form FDA 3881) (5) 510(k) Summary or 510(k) Statement (6) Truthful and Acc...
Indications for Use Statement (Form FDA 3881) 510(k) Summary or 510(k) Statement Truthful and Accuracy Statement Class III Summary and Certification Financial Certification or Disclosure Statement 具体内容: 1.Form FDA 3514 是FDA提供的固定格式的可以填写的一个PDF文件,只需要根据申报情况实际填写相关内容...
Indications for Use 适应症 器械诊断、治疗、预防何种疾病,减轻何种疾病带来的痛苦,在什么情况下这些用途得以实现,还包括器械适用的人群。在提交的文件中,该描述要保持一致(FormFDA 3881*) 510(k) Summary or 510(k)Statement 510(k)的需要包含具体信息,证明新器械与对比器械是如何实质对比的 ...
Table 3:Required sections for safety and performance-based pathway. Medical Device User Fee Cover Sheet (Form FDA 3601) CDRH Premarket Review Submission Cover Sheet (Form FDA 3514) 510(k) Cover Letter Indications for Use Statement (Form FDA 3881) ...