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Food and Drug Administration, Content of Premarket Submissions for Management of Cybersecurity in Medical Devices-Draft Guidance for Industry and Food and Drug Administration Staff (June 14, 2013) (full-text).


This guidance has been developed by the FDA to assist industry by identifying issues related to cybersecurity that manufacturers should consider in preparing premarket submissions for medical devices. The need for effective cybersecurity to assure medical device functionality has become more important with the increasing use of wireless, Internet- and network-connected devices, and the frequent electronic exchange of medical device-related health information.

The recommendations contained in this guidance document are intended to supplement FDA's "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" and "Guidance to Industry: Cybersecurity for Networked Medical Devices Containing Off-the-Shelf (OTS) Software."

This draft guidance was finalized in October 2014.[1]