The following guideline can be ordered through the address listed in the "Source/Publisher"-category. In cases in which you can order through the Internet we have established a hyperlink.
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.
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