Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

What is common practice regarding human factors testing for a consumer-user medical device in terms of language requirements.  For example if a product is available initially with instructions in English only and the company wishes to add other languages, should we be repeating human factors testing with all the translations or is some certification of the translation sufficient to say the original human factors testing in English was still applicable?  Does FDA have any specific expectations? 

Is it different globally - is all testing expected to be repeated for each language?

Usually not, though it may depend on risk. If the usability of a device is highly dependent on the instructions, and some unexpected ambiguity could lead to safety problems, you might need additional validation of the translations.

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Anne LeBlanc
United States
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Original Message:
Sent: 05-May-2022 15:21
From: Anonymous Member
Subject: Human Factors

This message was posted by a user wishing to remain anonymous

What is common practice regarding human factors testing for a consumer-user medical device in terms of language requirements.  For example if a product is available initially with instructions in English only and the company wishes to add other languages, should we be repeating human factors testing with all the translations or is some certification of the translation sufficient to say the original human factors testing in English was still applicable?  Does FDA have any specific expectations?

Is it different globally - is all testing expected to be repeated for each language?