FDA's Kevin Fu on Threat Modeling for Medical Devices HealthInfoSec) • April 9, 2021 13 Minutes Twitter Kevin Fu, acting director of medical device cybersecurity, U.S. Food and Drug Administration More precise and pervasive cybersecurity threat modeling during manufacturers' development of medical devices - and also during the regulatory product review process - is critical for risk mitigation, says Kevin Fu, new acting director of medical device cybersecurity at the Food and Drug Administration. "Cybersecurity is a foreseeable risk, so it shouldn't be a surprise that we see vulnerabilities in software and hardware that are components to medical devices," he says in an interview with Information Security Media Group. "The big challenge is how to become less reactive and more proactive."