Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions

Cybersecurity threats to the healthcare sector have become more frequent and more severe, carrying increased potential for clinical impact. Cybersecurity incidents have rendered medical devices and hospital networks inoperable, disrupting the delivery of patient care across healthcare facilities in the U.S. and globally.

Such cyber attacks and exploits may lead to patient harm as a result of clinical hazards, such as delay in diagnoses and/or treatment.