Update

Every software update is a design change that goes through the quality system. Many cybersecurity updates are routine and do not need a new marketing submission, but each still needs evaluation and records.

corrective, preventative, adaptive, or perfective modifications made to software of a medical device.

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