Updatability and patchability

FDA treats this as a design property to plan from the start, because a device that cannot be updated cannot respond to new vulnerabilities. The update mechanism itself also has to be secure.

the ease and timeliness with which a device and related assets can be changed for any reason (e.g., feature update, security patch, hardware replacement).

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