Anyone know the self-selection study for home use medical device

S

sunshineshu

#1
Our product is a home-use medical device, and FDA require us to submit a self-selection study report. We reference the Guidance for Industry Self-selection studies for nonprescription drug products, do anyone know have any other document can be reference?
 
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Pads38

Trusted Information Resource
#2
As the self-selection guidance document is specifically a drug guidance and you are dealing with a device it suggests that there is no better guidance document available.

There is a further document on Label Comprehension, but that is also a drug guidance document.
https://www.google.co.uk/url?sa=t&r...Vt-auZj1TCapP7zpwcMWKtQ&bvm=bv.91071109,d.d2s

As the self-selection study is a form of Usability testing you could look for general Usability guidance such as here:-
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HumanFactors/

And you could look at standards such as HE75 and IEC62366, but this may all be somewhat excessive.

The original guidance document does seem relatively useful (and short!). Bear in mind what it says in the introduction -
We recognize that self-selection data can be obtained in a variety of different ways and that each development program raises distinct issues for which flexibility and creativity is important.
 
I

isoalchemist

#3
I would request clarification on the specific guidance they want. I tend to agree with PADS38 that they may be talking usability.
 
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