Cybersecurity

FDA treats cybersecurity as part of device safety and of the quality system, not as a separate IT concern. It has to be designed in, documented in the premarket submission and maintained after launch.

the process of preventing unauthorized access, modification, misuse or denial of use, or the unauthorized use of information that is stored, accessed, or transferred from a medical device to an external recipient.

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