Cryptography

Devices should use established, current cryptographic methods rather than custom ones. Planning for algorithm updates over the device's life is part of the design.

the discipline that embodies the principles, means, and methods for providing information security; including confidentiality, data integrity, non-repudiation, and authenticity.

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