Precautions

Precautions sit in labeling between warnings and general instructions. In the 510(k) change guidance, adding or changing precautions is a labeling change that is assessed for its effect on safety and effectiveness.

Precautions describe any special care to be exercised by a practitioner or patient for the safe and effective use of a device. This definition also includes limitations stated for IVDs.

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)