SECTION 2.SCOPE 第 2 部分 范围 This guidance describes how certain provisions of the medical device Quality System regulation apply to software and the agency’s current approach to evaluating a software validation system.For example, this document lists elements that are acceptable to the FDA for the validation of software; however, it does not list all of the activities and tasks that must, in all instances, be used to comply with the law.本指导描述了医疗器械质量系统法规的某些条款如何应用到软件，以及 FDA 评价一个软件验证系统的 现行方法。例如，本文列出了 FDA 对于软件验证的可接受元素；但是，并未列出在一切情况下必须遵 循法律的所有活动和任务。 The scope of this guidance is somewhat broader than the scope of validation in the strictest definition of that term.Planning, verification, testing, traceability, configuration management, and many other aspects of good software engineering discussed in this guidance are important activities that together help to support a final conclusion that software is validated.严格上讲，本指导的应用范围比验证的范围更广泛一些。计划、确认、测试、追溯性、配置管理及本 指导中讨论的良好软件工程的许多其他方面是重要的活动，它们有助于支持一个最终结论 - 软件是已验 证过的。 This guidance recommends an integration of software life cycle management and risk management activities.Based on the intended use and the safety risk associated with the software to be developed, the software developer should determine the specific approach, the combination of techniques to be used, and the level of effort to be applied.While this guidance does not recommend any specific life cycle model or any specific technique or method, it does recommend that software validation and verification activities be conducted throughout the entire software life cycle.本指导建议将软件生命周期管理和风险管理活动进行整合。根据预期用途和与开发的软件相关联的安 全风险，软件开发人员应确定特定方法，使用的多个技术的组合，以及应用尝试程度。虽然本指导未 推荐任何特定生命周期模式，或任何特定技术或方法，但建议整个软件生命周期需进行软件验证和确 认活动。 Where the software is developed by someone other than the device manufacturer (e.g., off-the-shelf software) the software developer may not be directly responsible for compliance with FDA regulations.若软件由某人而非器械生产商开发，如成品组件软件，这个软件开发者可能不直接负责 FDA 法规的符 合性。 In that case, the party with regulatory responsibility (i.e., the device manufacturer) needs to assess the adequacy of the off-the-shelf software developer’s activities and determine what additional efforts are needed to establish that the software is validated for the device manufacturer’s intended use.