Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

A question came up on whether we need to repeat human factors testing if the labeling and user interface on our medical device (software driven medical device) is translated into another language.  If everything else is the same (same statements, but translated, etc.) and only the language is changed, can we leverage the original human factors testing completed in English, for example?  Does FDA expect it to be repeated? 

What if we decide to go to Europe?  Do we need to repeat for each new language?

This message was posted by a user wishing to remain anonymous

See related threads:

Human Factors
https://connect.raps.org/communities/community-home/digestviewer/viewthread?GroupId=97&MessageKey=b8e497be-29d3-42ae-829c-2700c50dd9ff&CommunityKey=5af348a7-851e-4594-b467-d4d0983b6d89


EU MDR Translation Compentency Requirements
https://connect.raps.org/communities/community-home/digestviewer/viewthread?GroupId=97&MessageKey=203d02bf-172d-4cb6-86d3-d4b6dd755531&CommunityKey=5af348a7-851e-4594-b467-d4d0983b6d89

Original Message:
Sent: 06-May-2022 15:10
From: Anonymous Member
Subject: Human Factors - Language changes

This message was posted by a user wishing to remain anonymous

A question came up on whether we need to repeat human factors testing if the labeling and user interface on our medical device (software driven medical device) is translated into another language.  If everything else is the same (same statements, but translated, etc.) and only the language is changed, can we leverage the original human factors testing completed in English, for example?  Does FDA expect it to be repeated?

What if we decide to go to Europe?  Do we need to repeat for each new language?