Patch

For medical devices, a patch is a software change and goes through change control, including verification and an assessment of whether a regulatory submission is needed. FDA expects manufacturers to plan for timely cybersecurity patches for as long as the device is supported.

a “repair job” for a piece of programming; also known as a “fix.” A patch is the immediate solution to an identified problem that is provided to users. The patch is not necessarily the best solution for the problem, and the product developers often find a better solution to provide when they package the product for its next release. A patch is usually developed and distributed as a replacement for or an insertion in compiled code (that is, in a binary file or object module). In many operating systems, a special program is provided to manage and track the installation of patches.

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