The Food and Drug Administration's Policies and Procedures Should Better Address Postmarket Cybersecurity Risk to Medical Devices

We conducted this audit because OIG had identified ensuring the safety and effectiveness of medical devices and fostering a culture of cybersecurity as top management challenges for HHS. We also considered public and Congressional interest in medical device cybersecurity risks to patients and the Internet of Things. The Food and Drug Administration (FDA) is the HHS operating division responsible for assuring that legally marketed medical devices are safe and effective.