摘要:描述了在同情请求的情况下，处理医生使用未经批准的系统的请求的程序。仅适用于美国医生的请求。包括评估标准、记录批准、交叉参考信、获得FDA批准以及提供后续信息。包括遵守适用的FDA法规的规定。包括的章节:目的、范围、责任、参考文件和适用文件、材料和设备、健康和安全注意事项、文件要求和程序包括的附件/附录:同情性抗辩检查清单和信息、申请一次性调查设备豁免（IDE）的说明关于本文件: 这不是一个通用模板，它是一个5页的程序，实际上是在FDA监管机构的临床研究操作中创建和使用的。公司特定信息（名称、地址、一些图片、专有产品信息等）已被编辑，但内容和格式已基本保留。购买理由:将其作为你自己文档项目的起点，将你文档的质量与你所在行业的同行进行比较，了解你所在行业的其他公司在做什么，谁将从中受益:临床研究协会临床研究经理监管事务人员

Summary:Describes a procedure for handling physician requests for use of ¿unapproved¿ systems in the case of a compassionate plea. Applies to requests from US-based physicians only. Covers evaluation criteria, documenting approval, cross-reference letters, obtaining FDA approval, and providing follow-up information. Includes provisions for compliance with applicable FDA regulations.Included Sections:Purpose, Scope, Responsibility, References and Applicable Documents, Materials and Equipment, Health and Safety Considerations, Documentation Requirements, and ProceduresIncluded Attachments/Appendices:Compassionate Plea Check List and Information, Directions for Requesting A Single Use Investigation Device Exemption (IDE)About This Document:This is not a generic template, it's a 5-page procedure that was actually created and used in the Clinical Research operations of a FDA-regulated establishment. The company-specific information (names, addresses, some images, proprietary product information, etc.) has been redacted but the content and format have been largely preserved.Reasons to Buy:Use it as a starting point for your own documentation projectCompare the quality of your documents against your industry peersLearn what other companies in your industry are actually doingWho Will Benefit:Clinical Research AssociatesClinical Study ManagersRegulatory Affairs Personnel