Trustworthy device

FDA frames cybersecurity as part of whether a device can be trusted to work safely, not as an add-on. The four elements make a useful checklist for a design review.

a medical device that: (1) is reasonably secure from cybersecurity intrusion and misuse; (2) provides a reasonable level of availability and reliability; (3) is reasonably suited to performing its intended functions; and (4) adheres to generally accepted security procedures to support correct operation.

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