Regulatory Open Forum

Can Usability Validation be conducted as Part of an Animal Study 

For the usability evaluation you must define typical users and use scenarios. If you can cover all of those with an animal study, that would be fine. However, I have my doubts and I can't think of a scenario where this would work.

Thank you, Ronald. 

An issue with the Animal model is that it does have the disease to be treated. Other than that, we have the typical user, and we cover all use scenarios, including critical tasks. another issue is the sample size. we can't have the sample size required by the FDA. but we can still collect usability data in that simulated env.

Do you see any other issues? 

Yes, it can. At least sometimes. At least in part. Maybe the question is, in this case, should it be?

Is it a veterinary product?

Will the exercise cause additional harm to the animals?