Unresolved anomaly

Premarket software documentation lists unresolved anomalies with their impact and justification. FDA expects their cybersecurity impact to be considered too, since a defect that seems harmless can become an entry point.

a defect that still resides in the software because a sponsor deemed it appropriate not to correct or fix the anomaly, according to a risk-based rationale about its impact to the device’s safety and effectiveness.

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