FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices
Title:
FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices
Origin/Publisher:
FDA, http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm089593.pdf
Document Type:
Guidance
Content:
This document provides guidance on the regulatory review of premarket submissions for software
contained in medical devices.