Resilience

In FDA cybersecurity guidance, resilience shifts the focus from preventing every attack to making sure essential functions continue and the device returns to normal operation. Designers show it through features such as safe degraded modes and recovery mechanisms.

the ability of an information system to continue to: (i) operate under adverse conditions or stress, even if in a degraded or debilitated state, while maintaining essential operational capabilities; and (ii) recover to an effective operational posture in a time frame consistent with mission needs.

FDA guidance: Cybersecurity in Medical Devices: Quality Management System Considerations and Content of Premarket Submissions (February 2026), Appendix 5, Terminology