Validating summative assessment
How long that is will vary, depending upon what would happen in real life and the impact of training decay on the use-related risks that you’ve identified for your device.The important thing is to consider this topic and document your rationale for the chosen approach.It’s very much a case of using formative studies as building blocks that provide a robust foundation for your validation test. However, testing that demonstrates the “user requirements” or User Needs have been met will henceforth be referred to as “Human Factors Validation Testing”.
We’ve been fortunate to have supported several clients in developing and submitting draft protocols to CDRH, so have benefited from a “heads up” about many of the changes that are now embodied in this final guidance document.
However, the agency are open to considering exceptions, on a case by case basis, where there is a sound rationale that addresses the differences.
In any case, as you might expect, the device, labelling and training must be those that would be used in the US.
Rather, the testing needs to be comprehensive, so that the results can be related to actual use.
If your device is intended to treat patients with a condition that can cause them to have functional limitations, these conditions must be represented during both the formative evaluations and your HFE validation study.