Class II Medical Device Submission - Human Factors Study Requirements

J

jessglud

#1
I am looking to define the submission requirements for an upcoming class II medical device 510(k). We have human factors requirements defined in the development documentation. The question is do we need to perform a human factors study to validate the human factors rerquirements we've established.
 
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M

MIREGMGR

#2
We have human factors requirements defined in the development documentation. The question is do we need to perform a human factors study to validate the human factors rerquirements we've established.
Maybe I don't fully understand your scenario, but I don't think you have to validate your product requirements or specifications, unless either a standard might be relevant and there could be a question as to whether your requirements would satisfy that standard, or a substantive question might exist as to whether your requirements would result in your product being clinically safe and effective.

You probably do, on the other hand, have to determine in a valid manner whether your product meets whatever requirements you've established.
 

yodon

Staff member
Super Moderator
#3
Ideally, you have a V&V Plan that would define how you verify the requirements are met and validate that user needs are met. Otherwise, when you're asked how you validated the design, you might not have a good answer!

Since you're filing a 510(k), presumably there's a predicate device. As such, there's probably already something of a human factors standard or expectation. If you dramatically change that aspect then you might have a hard time showing that the user needs are met unless you do something like a human factors study.

So the bottom line is that you do need to plan out what you intend to do such that it's defensible. Consider risk to assess the types of validation testing to perform. If there's no risk of misuse or erroneous use due to how you implement the human factors aspect, then maybe a study is warranted.
 
D

donnaj8887

#4
Ideally, you have a V&V Plan that would define how you verify the requirements are met and validate that user needs are met. Otherwise, when you're asked how you validated the design, you might not have a good answer!

Since you're filing a 510(k), presumably there's a predicate device. As such, there's probably already something of a human factors standard or expectation. If you dramatically change that aspect then you might have a hard time showing that the user needs are met unless you do something like a human factors study.

So the bottom line is that you do need to plan out what you intend to do such that it's defensible. Consider risk to assess the types of validation testing to perform. If there's no risk of misuse or erroneous use due to how you implement the human factors aspect, then maybe a study is warranted.
Great post! It's very nice. Thank you so much for your post.
 
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