Is Human Factors testing mandatory for a 510(k) submission?

Dobby1979

Involved In Discussions
#1
Hi All.

Is HF testing mandatory for a 510(k) submission? Reading the guidance and various discussions it appears that it is recommended but not mandatory? I want to try and gauge the level we need for our first submission! The medical device is a software product, not doing anything radical or life-threatening. We have considered HF during our risk analysis but do we need to go full board on this and have separate HF plans etc. If so, does anyone have any templates / bullet points of how this should be addressed.

Thanks.
 
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Enternationalist

Involved In Discussions
#5
Yes. We will claim compliance to 13485 and 62304.
7.3.3 a) in ISO 13485 will ask you to include usability requirements according to intended use.

IEC 62304 will ask you for usability related requirements as part of section 5.2.2 as well as references to IEC 62366 sprinkled throughout.

I would probably go straight to looking into IEC 62366 and determining how well it matches up with what you're already doing and what requirements are applicable to you.

Are you a PC/web application, or is your software meant to be running embedded on a medical device?
 

Dobby1979

Involved In Discussions
#6
7.3.3 a) in ISO 13485 will ask you to include usability requirements according to intended use.

IEC 62304 will ask you for usability related requirements as part of section 5.2.2 as well as references to IEC 62366 sprinkled throughout.

I would probably go straight to looking into IEC 62366 and determining how well it matches up with what you're already doing and what requirements are applicable to you.

Are you a PC/web application, or is your software meant to be running embedded on a medical device?
We are a stand-alone medical device, not embedded.

Is IEC 62366 mandatory? We did have a look at this and did not feel that it was relevant to our software.
 

mihzago

Trusted Information Resource
#8
HF testing (i.e. usability study if that's what you mean by testing) is not always required, but you have to demonstrate it is not required through a usability assessment. That's where the IEC 62366 and the FDA's guidance on Human Factors comes in.
If you perform the assessment (e.g. analyze the intended use, user characteristics, use environment, use characteristics, perform task analysis, etc.) and determine there are no use related risks that could cause serious harm (aka critical tasks), then a study may not be needed.

Here's a direct quote from an FDA reviewer in a pre-sub:
"A human factors study is recommended if there are device user tasks which, if performed incorrectly or not performed at all, would or could cause serious harm to the device user and would therefore be considered critical tasks."
 
#10
HF testing (i.e. usability study if that's what you mean by testing) is not always required, but you have to demonstrate it is not required through a usability assessment. That's where the IEC 62366 and the FDA's guidance on Human Factors comes in.
If you perform the assessment (e.g. analyze the intended use, user characteristics, use environment, use characteristics, perform task analysis, etc.) and determine there are no use related risks that could cause serious harm (aka critical tasks), then a study may not be needed.

Here's a direct quote from an FDA reviewer in a pre-sub:
"A human factors study is recommended if there are device user tasks which, if performed incorrectly or not performed at all, would or could cause serious harm to the device user and would therefore be considered critical tasks."

@Enternationalist, I am new to HFE,UX and trying to understand if a summative test is needed if it is a Class 1 510K exempt medical device that DOES have use related errors/tasks that if preformed incorrectly could cause serious harm.
I am more solid in knowing when it is Class 2 or 3, but not so much when it is a Class 1 510k exempt with no submission required.
 
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