Where do you place Human Factors report in a 510(k) application?


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Hi folks,
FDA Guidance for the Content of Premarket Submissions does not clearly specifies where to include the Human Factors report.
I have seen applications where the Human Factors report was part of "Performance testing- Bench" which is not correct, and I have seen applications where Human Factors report had its own section - "Performance testing- Human Factors".

What is your experience?



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It has been a while since I reviewed one of our 510(k) submissions, but IIRC our submission had a section specifically dedicated to user validation. I want to write that for our submissions, we've had certain classes of documents that naturally aggregate to explain various elements of our submission.

My own role for most of our submissions was more focused on risk management, and so while I am sure that our summative testing (and associated reports) were included (as OE for control of risks) along with our use cases (and associated files like patient/user needs) that motivated the direction/organization of the risk management files... I can't say that we would have included details of formative testing in the submission itself.
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