Appendix 1 – Medical Device User Fee Cover Sheet 8. USER FEE PAYMENT AMOUNT SUBMITTED FOR THIS PREMARKET APPLICATION MDUFMA User Fees Cover Sheet The Medical Device User Fee Cover Sheet is required for your Medical Device Application Submission. After completing the cover sheet, you will be assi...
青云英语翻译 请在下面的文本框内输入文字,然后点击开始翻译按钮进行翻译,如果您看不到结果,请重新翻译!Medical Device User Fee Cover Sheet (Form FDA 3601)选择语言:从 到 翻译结果1翻译结果2 翻译结果3翻译结果4翻译结果5 翻译结果1复制译文编辑译文朗读译文返回顶部 医疗器械用户收费封面(FDA 3601表格) 翻译...
1. Medical Device User Fee Cover Sheet (Form FDA 3601)医疗器械使用者费(注册费)首页,即向FDA付款后收到的付款证明 2. CDRH Premarket Review Submission Cover Sheet (CDRH: Center for Devices and Radiological Health器械与辐射健康中心) CDRH上市前审查递交文件封面 3. 510(k) Cover Letter 510(k)附信...
VOL-001-Medical Device User fee Cover sheet( form FDA3601) 2) 上市前提交申请表:此部分包括申请人(或联系人)和企业的基本信息、510(K)递交的目的、申请上市器械的名称型号和分类资料、进行实质等效比较的产品(Predicate Device)名称及其510(K)号码; VOL-002-CDRH Premarket Review Submission cover sheet ( f...
FDA-510K所需准备的文件
Medical Device User FeeCover Sheet 资料提交之前,缴纳审核的费用填写的表格(Form FDA 3601*) CDRH Premarket ReviewSubmission Cover Sheet 此次申请的封页面(Form FDA 3514*) Certification of Compliance with ClinicalTrials.gov Data Bank 需要做临床试验的器械,需要先满足临床相关的要求,这里需要提交符合临床数据...
(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 ...
该法案的实施目的与PDUFA类似,都是为FDA提供资源以确保恰当的提交评审周期。5年后,《医疗器械使用者付费修正案》 Medical Device User Fee Amendments of 2007, MDUFA II获得再授权,提出了一个更加严谨的绩效目标,并要求FDA向国会提交绩效报告与财务报告。以下是至今所有已生效MDUFA以及对应的财年期限。
FDA-510K所需准备的文件 序号1234 TitleMedicalDeviceUserFeeCoverSheet(FormFDA3601)CDRHPremarketReviewSubmissionCoverSheet510(k)CoverLetterIndicationsforUseStatement 文件名缴费证明文件CDRH上市前审核提交表格510k封面信件预期用途 5 510(k)Summaryor510(k)510k总结或510k声明Statement 67 TruthfulandAccuracyStatement...
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