Encryption

FDA expects manufacturers to consider confidentiality for data stored on a device and data in transit. Encryption is one control for this, and how keys are generated, stored and updated matters as much as the algorithm.

is the cryptographic transformation of data (called “plaintext”) into a form (called “ciphertext”) that conceals the data’s original meaning to prevent it from being known or used.

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