FDA deficient on device cybersecurity readiness, watchdog says

Nov 02

Susan Kelly

HHS’ office of inspector general in a new audit called FDA’s policies and procedures deficient for addressing postmarket cybersecurity threats to medical devices.
Specifically, FDA had not adequately tested its ability to respond to cybersecurity emergencies involving devices, and in two of 19 district offices had no written standard operating procedures covering recalls of vulnerable devices, OIG found.
FDA said the report paints “an incomplete and inadequate” picture of the agency’s oversight of medical device cybersecurity.