本文件为医疗器械中所含软件上市前提交的监管审查提供指导。它取代了1991年发布的“接受510（k）审查的计算机控制医疗设备审查员指南”。本文件适用于包含软件的医疗设备的所有类型的上市前提交，以及其自身视为医疗设备的软件产品。这包括上市前通知（510（k）、上市前申请（PMA）、试验装置豁免（IDE）和人道主义装置豁免（HDE）。

This document provides guidance on the regulatory review of premarket submissions for software contained in medical devices. It replaces the "Reviewer Guidance for Computer Controlled Medical Devices Undergoing 510(k) Review" issued in 1991. This document applies to all types of premarket submissions for medical devices containing software and for software products considered by themselves to be medical devices. This includes premarket notifications (510(k)s), premarket applications (PMAs), investigational device exemptions (IDEs), and Humanitarian Device Exemptions (HDEs).