EU Useability Study for FDA? Class II Medical Device



Hi Everyone,

Long time lurker, first time poster. I have a question that I thought I would put to the collective wisdom of the group. I realize that this question is not directly relating to the standard but also to the FDAs guidance document so this may not be the appropriate forum for the question.

So, I am preparing a 510(k) submission for a device that has been used in the EU for several years. Management do not want to spend the $$ to conduct a U.S. based useability study and instead want to leverage the years of experience with EU doc/users. FDA guidance recommends that testing should be carried out with U.S. based users for devices to be marketed in the U.S.

Does anyone have any experience trying to leverage such non-U.S. based data ? any guesses on chances of success with an examiner ?




Super Moderator
Re: EU Useability Study for FDA?

First off, what class is your device?

Second, you mention a guidance, but have you seen this one (it's draft but, as they say, reflects current thinking at FDA): (broken link removed)


  • CDRH 2014-608 guidance Acceptance of OUS 4-8-15.pdf
    648.7 KB · Views: 218


Re: EU Useability Study for FDA?

Thanks for your reply!

The device is a Class II electrical device with a touchscreen user interface. I had not seen this draft guidance, which is quite informative. It seems that FDA might accept EU based usability data afterall. It may be worth speaking with them directly prior to making the submission in order to check the strategy is accetable to them.


62366 is an "FDA Consensus Standard" - that is it is recognised by FDA, so Usability processes based on that standard should be accepted.

See here for the different versions:
Put 62366 into the standard search box.

Note that the latest version of the standard has an Annex (C) that details a Usability process for legacy devices; - that is ones that have a long history of use. So there is a formal way to present valid data from existing use.

Note that simply stating "we have sold xx thousand units and there is no problem" is not sufficient and would give the impression to the reviewer that you are "trying to get away with it" and trigger more rigorous review of your application.

The guidance document that yodon has identified is extremely important as it sets out the difficulties that FDA may have with non-US data. Note that for Usability factors of language differences and cultural differences should be considered.


Involved In Discussions
The FDA no longer accept 62366 for usability, they have obsoleted it in favour of 62366-1.
I would say if you present your usability data in the form described in 62366-1 you should have no problem.
I am not aware of them insisting that usability data has to be US based - Clinical evaluation/investigation maybe - but not usability as far as I am aware.


This is directly from the FDA guidance document:

"For the results of the human factors validation testing to demonstrate safe and effective use by users in the United States, the participants in the testing should reside in the US. Studies performed in other countries or with non-US residents may be affected (positively or negatively) by different clinical practices that exist in other countries......Exceptions to this policy will be considered on a case-bycase basis and will be based on a sound rationale that considers the relevant differences from conditions in the US.."


Applying Human Factors and Usability Engineering to Medical Devices, Feb 3 2016.

I`m not allowed to post links yet but it`s freely available on the FDA website.
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