Fuzz testing

FDA lists fuzz testing among the cybersecurity tests expected in premarket submissions, alongside tests such as penetration testing. It often finds crashes and input handling flaws that ordinary functional tests miss.

process of creating malformed or unexpected data or call sequences to be consumed by the entity under test to verify that they are handled appropriately.

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