User evaluation for self monitoring blood glucose test systems

[Shawna]

Dear forum fellows,

Need help or experience here. We have a self monitoring blood glucose meter for lay users to use at home. According to the FDA guidance https://www.fda.gov/media/87721/download, more than 350 lay users should be recruited to use our blood glucose meter to test their blood glucose and evaluate the device in a questionnaire, as so called Method Comparison/User Evaluation in Section C of the guidance. The study should be conducted under conditions that reflect the expected use of the device by the intended use population.

My questions is, could this user evaluation/method comparison study be done in countries out of US? If we outsource this study to other countries like China or India, is it allowed by FDA? Can we only recruit US citizens who live in the foreign countries like white person, black person at a certain ratio similar as the US? Any help or suggestions is highly appreciated.

Shawna

 

[chris1price]

The question would be, do the users in China or India use the product in the same was as a US user? For example could a Chinese user read and obey the US instructions, which have to be in English (see page 13)? Similarly, on page 11 it says "The subjects you enroll in the method comparison/user study should accurately reflect the intended use population of the SMBG. " So you need the same racial mix, age and sex as the target population. I can't see Chinese or Indian subjects meeting this criteria.

 

[Shawna]

The question would be, do the users in China or India use the product in the same was as a US user? For example could a Chinese user read and obey the US instructions, which have to be in English (see page 13)? Similarly, on page 11 it says "The subjects you enroll in the method comparison/user study should accurately reflect the intended use population of the SMBG. " So you need the same racial mix, age and sex as the target population. I can't see Chinese or Indian subjects meeting this criteria.

What you said makes sense. We are just wondering if we recruit the US persons who live in China or india with same racial mix, age and sex as the target population, for the user evaluation. Is it ok with FDA? Any comments are apprieciated.

 

[chris1price]

I suspect the work needed to prove the people in china or India match the intended US population will be greater just doing the study in US in the first place. You could always try submitting the question to FDA on a QSUB.

 

[Shawna]

THANKS MUCH