Citation[]
Food and Drug Administration, Content of Premarket Submissions for Management of Cybersecurity in Medical Devices (Oct. 2, 2014) (full-text).
Overview[]
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 was 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.
A draft of this guidance was published in June 2013.[1]