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GUIDANCE DOCUMENT

Content of Premarket Submissions for Management of Cybersecurity in Medical Devices Guidance for Industry and Food and Drug Administration Staff October 2014

Final
Docket Number:
FDA-2013-D-0616-0001
Issued by:
Guidance Issuing Office
Center for Devices and Radiological Health

The need for effective cybersecurity to assure medical device functionality and safety 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. This guidance has been developed by the FDA to assist industry by identifying issues related to cybersecurity that manufacturers should consider in the design and development of their medical devices as well as in preparing premarket submissions for those devices. 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.”
 


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All written comments should be identified with this document's docket number: FDA-2013-D-0616-0001.