FDA finalizes guide for premarket considerations to address medical device cybersecurity risks

The Food and Drug Administration has finalized non-binding guidance for medical devices to assist industry with establishing processes for cybersecurity to be included for review in the premarket phase.

“This guidance provides FDA’s recommendations to industry regarding cybersecurity device design, labeling, and the documentation that FDA recommends be included in premarket submissions for devices with cybersecurity risk,” the FDA says in a Federal Register notice published June 27 announcing the availability of the guidance.

The notice says, “Additionally,...