Contraindications

Removing a contraindication widens how a device may be used and is a change to assess under FDA's guidance on when a new 510(k) is needed. Contraindications should come from the risk analysis and clinical data, not be added as a general safety net.

Contraindications describe situations in which the device should not be used because the risk of use clearly outweighs any reasonably foreseeable benefits.

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)