FDA Issues Guidelines for Cybersecurity Management in Medical Devices

WASHINGTON, D.C. — The Food and Drug Administration has issued a draft guidance for the content of premarket submissions for the management of cybersecurity in medical devices, cautioning that cybersecurity threats to the healthcare sector have become more frequent and severe.

In the Oct. 18 document, the FDA explained that the need for effective cybersecurity to ensure medical device functionality and safety is now more important due to the increasing use of wireless, Internet- and network-connected devices, portable media, and the frequent electronic exchange of health information.

“Cybersecurity incidents have rendered medical devices and hospital networks inoperable, disrupting the …