Anomaly

In premarket submissions, FDA expects known anomalies to be listed and assessed, including any with security impact. An anomaly is not automatically a defect to be fixed before release, but each one needs a documented decision.

any condition that deviates from the expected based on requirements specifications, design documents, standards, etc. or from someone’s perceptions or experiences. Note 1 to entry: ANOMALIES can be found during, but not limited to, the review, test, analysis, compilation, or use of HEALTH SOFTWARE or applicable documentation. [SOURCE: Based on IEEE 1044:1993, 3.1]

IEC 82304-1:2016, clause 3.2

any condition that deviates from the expected based on requirements specifications, design documents, standards, etc. or from someone’s perceptions or experiences. ANOMALIES may be found during, but not limited to, the review, test, analysis, compilation, or use of MEDICAL DEVICE SOFTWARE or applicable documentation NOTE Based on IEEE 1044:1993, definition 3.1.

IEC 62304:2006+AMD1:2015, clause 3.2

any condition that deviates from the expected behavior based on user needs, requirements, specifications, design documents, or standards.

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