FDA issues guidance for post-market management of medical device cybersecurity

The Food and Drug Administration last week issued final guidance on the postmarket management of medical device cybersecurity. The guidance follows earlier final guidance on medical device premarket cybersecurity. “With this guidance, we now have an outline of steps the FDA recommends manufacturers take to remain vigilant and continually address the cybersecurity risks of marketed medical devices,” wrote Suzanne Schwartz, M.D., associate director for science and strategic partnerships at the FDA’s Center for Devices and Radiological Health. “Central to these recommendations is FDA’s belief that medical device manufacturers should implement a structured and comprehensive program to manage cybersecurity risks.”