Warnings

Warnings are distinct from precautions and contraindications in the labeling. Adding or changing a warning is a labeling change that may affect a 510(k), which is why FDA's change guidance defines the term.

Warnings describe serious adverse reactions and potential safety hazards that can occur in the proper use or misuse of a device, along with consequent limitations in use and mitigating steps to take if they occur.

FDA guidance: Deciding When to Submit a 510(k) for a Change to an Existing Device (October 2017), Appendix C, Significant Terminology (Precautions, Warnings, and Contraindications)