FDA Guidance: Cybersecurity for Networked Medical Devices Containing Off-the-Shelf (OTS) Software, 1/05

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In January 2005, the US FDA published this guidance for industry: Cybersecurity for Networked Medical Devices Containing Off-the-Shelf (OTS) Software.

This document is written in question-and-answer format and contains information regarding responsibilities, validation, and reporting of software security patches for networked medical devices.