510(k) vs. CE Marking Summative Usability Testing Expectations

V

Varman04

#1
Hi All,

Help me understand if according to the new harmonized 62366 standards for medical devices usability, If I have a CE marked medical device and I want to apply 510(k) for the US, can I use the same summative usability test report and vice versa? Does either of the institutions expect summative studies to be repeated with local population users?

Please clarify
 
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yodon

Staff member
Super Moderator
#2
My practical experience here is rather limited so I'm anxious to follow this discussion.

You should be aware of a couple of FDA guidance docs. This first one, Applying Human Factors and Usability Engineering: https://www.fda.gov/ucm/groups/fdagov-public/@fdagov-meddev-gen/documents/document/ucm259760.pdf gives a pretty good description of the relation of summative studies from the FDA perspective.

The second one describes what's expected if you do want to use studies done from outside the US: Acceptance of Medical Device Clinical Data from Studies Conducted Outside the United States: https://www.fda.gov/ucm/groups/fdagov-public/@fdagov-meddev-gen/documents/document/ucm443133.pdf

Hope these help.
 
#3
Here is what the FDA says (bolding added for emphasis):

"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, different units of measure used, language differences that change the way labeling and training are understood, etc. Exceptions to this policy will be considered on a case-by- case basis and will be based on a sound rationale that considers the relevant differences from conditions in the US. In addition to the user interface of the device, the labeling and training should correspond exactly to that which would be used for the device if marketed in the US."
 
V

Varman04

#4
Here is what the FDA says (bolding added for emphasis):



"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, different units of measure used, language differences that change the way labeling and training are understood, etc. Exceptions to this policy will be considered on a case-by- case basis and will be based on a sound rationale that considers the relevant differences from conditions in the US. In addition to the user interface of the device, the labeling and training should correspond exactly to that which would be used for the device if marketed in the US."


Hi,

Thanks a lot. Please enlighten me about the reverse scenario. For a product selling currently in the US, for getting a CE marking, can I use the same usability documentation or should i repeat the summative studies in Europe?


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#5
The short answer is yes, you should be fine using US data for an EU submission from a regulatory perspective. This may change and certainly should change given the often striking differences in product usage around the world but this is the current status quo. If you're willing to accept the commercialization risk of launching a product in an untested market then you can use data from US-based studies to support submission in the EU. However, in my experience, most mature companies have recognized the benefits of HF testing in all of their most important markets and proceed with research above and beyond what is required by notified bodies.
 
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