Performance specifications

Performance specifications are what malfunctions are measured against in FDA's reporting rules. In the 510(k) change guidance, changing a specification may call for testing and a new 510(k), depending on its effect on safety and effectiveness.

The performance characteristics of a device as listed in device labeling or in finished product release specifications. Some examples of performance specifications are measurement accuracy, output accuracy, energy output level, and stability criteria.

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