Malware

For connected devices, protection against malware is part of the cybersecurity design FDA expects to see in premarket submissions. Malware risk is also managed after release, through monitoring, updates and patches.

software or firmware intended to perform an unauthorized process that will have adverse impact on the confidentiality, integrity, or availability of an information system.

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