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FDA Publishes Draft Guidance on Medical Device Cybersecurity

Pacemaker cybersecurityFDA has published a draft of the guidance document that it has developed to assist industry by identifying issues related to cybersecurity that manufacturers should consider in preparing premarket submissions for medical devices.  This guidance document is 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”

According to the guidance, “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.”

Comments from the public are due to the FDA by September 12, 2013.

Click here for a pdf copy of the guidance document.

 

 
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