摘要:描述了收集有关可报告事件的信息并提交所需报告的程序。具体到向美国食品和药物管理局报告（向欧洲主管当局报告见SOP 090178）。适用于已上市的设备。不适用于在美国根据IDE分销的产品。包括定义、时间范围和报告要求、报告故障的时间范围、事件可能不可报告的情况、事件肯定可报告的情况以及文件。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:无关于本文件:这不是一个通用模板，它是一个6页的程序，实际上是在FDA的监管事务操作中创建和使用的- 受监管的机构。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，谁会从中受益:监管事务经理管理代表执行管理

Summary:Describes a procedure for collecting information regarding reportable events and filing the required reports. Specific to reporting to the U.S. Food and Drug Administration (see SOP 090178 for reporting to European Competent Authorities). Applies to marketed devices. Does not apply to products that are distributed under IDE in the United States. Covers definitions, time frames and reporting requirements, time frames for reporting a malfunction, cases where an event may not be reportable, cases where an event is definitely reportable, and documentation.Included Sections:Purpose, Scope, Responsibility, References and Applicable Documents, Materials and Equipment, Health and Safety Considerations, Documentation Requirements, and ProceduresIncluded Attachments/Appendices:NoneAbout This Document:This is not a generic template, it's a 6-page procedure that was actually created and used in the Regulatory Affairs 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:Regulatory Affairs ManagersManagement RepresentativesExecutive Management