FDA Case Presentations During Investigational Device Exemption (IDE) Clinical Trials
标准简介
Case Presentations During Investigational Device Exemption (IDE) Clinical Trials[附网盘链接]是于不久之前发布的FDA标准，适用于US。标准截图
![Case Presentations During Investigational Device Exemption (IDE) Clinical Trials[附网盘链接]](/img/20210914103605so4pd.jpg)
标准文档说明
标准文档类型为Case Presentations During Investigational Device Exemption (IDE) Clinical Trials[附网盘链接]高清PDF版本（文字版），标准文档内可进行搜索，可以复制原文，可粘贴。标准部分原文
Live Case Presentations During Investigational Device Exemption (IDE) Clinical Trials Guidance for Institutional Review Boards, Industry, Clinical Investigators, and Food and Drug Administration Staff This guidance represents the current thinking of the Food and Drug Administration (FDA or Agency) on this topic. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. To discuss an alternative approach, contact the FDA staff or Office responsible for this guidance as listed on the title page. I. Introduction The purpose of this document is to provide Institutional Review Boards (IRBs), industry, clinical investigators, and Food and Drug Administration (FDA) staff factors to consider when evaluating the appropriateness of a live case presentation within a clinical 1 2
investigation conducted under an investigational device exemption (IDE) application. This document provides guidance on important information about a live case presentation that should be provided as part of an original IDE application or a supplement to an IDE application when requesting inclusion of a live case presentation during a clinical investigation. Applications and supplements that include a live case presentation are referred to generally as “requests” throughout this document. A live case presentation is a live or pre-recorded broadcast of a surgical or percutaneous procedure, typically narrated by the operator (or a discussant other than the operator), with or without expert panel and/or audience interaction. These presentations are typically broadcast at scientific meetings to increase awareness of the clinical investigation and recruit 1
For purposes of this guidance, the terms “clinical investigation,” “investigation,” “study,” and “research” are used synonymously. 2
Although this guidance is written primarily for device investigations that require submission of an IDE application to FDA (e.g., significant risk devices), the information may also be applied to non-significant risk (NSR) device studies.
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