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

yodon

Staff member
Super Moderator
#11
Ignore the standards and regulations for just a minute and consider the true objective of the FDA is to ensure safe and effective products are put on the market (which arguably, after profitability, should also be the company's goal but let's not go there).

How do you KNOW that you've designed a system that is safe and the UI promotes safe and effective use? The formative and summative studies are intended to do just that: give you a high degree of assurance that your product won't harm someone (and won't get sued for putting an unsafe product on the market... oops, there I go again with the profitability thing). There may be other ways. If I was a company planning to put a device on the market that could cause serious harm if incorrectly used, I'd want to take every effort to minimize the likelihood of that.

If your product were to cause harm and FDA came a-knocking, do you think "well, since it was Class I, we didn't worry about safety" would be an argument they would accept?

Just because you may not be required to do something doesn't mean it's not a good idea.
 

mihzago

Quite Involved in Discussions
#12
FDA requires summative testing for any use risks that may cause serious harm.

If you have use related risks that may cause serious harm, are you sure it's Class I device with 510(k) exemption?
 
#13
yes, I'm sure. Without giving away too much info, it is nothing more than a fancy piece of tape meant to hold certain medical tubing. If those tubes (depending on the type) are dislodged by use errors (we harms of device dislodgement no injury, minor and severe). We go on a 5 point severity scale with 3 being serious, 4 critical and 5 catastrophic. The severity associated with device dislodgement severe is 3.
 

Ronen E

Problem Solver
Staff member
Super Moderator
#14
yes, I'm sure. Without giving away too much info, it is nothing more than a fancy piece of tape meant to hold certain medical tubing. If those tubes (depending on the type) are dislodged by use errors (we harms of device dislodgement no injury, minor and severe). We go on a 5 point severity scale with 3 being serious, 4 critical and 5 catastrophic. The severity associated with device dislodgement severe is 3.
Heh.
On a scale 1-5, 3 seems to be "medium" or "moderate" (the midpoint).
Not that you're not allowed to allocate whatever labels you choose, you definitely are. For example, one could use a 1-5 scale where 2 was "severe", and 1 "anything under severe", sure.
It just goes to show the importance of providing all relevant details when asking something here (actually, that's almost impossible), and why our ability to provide complete and reliable answers in this format is inherently limited.
 
#15
Nothing is mandatory for a 510(k) submission, except a demonstration of substantial equivalence to the predicate. And, really, not even that. You can submit anything you want.
 
#16
The severity associated with device dislodgement severe is 3.
I don't think any device that poses a risk of "severe" clinical harm a low-risk device, nor, I hope, would FDA. But the great thing about deciding that your device is Class I 510(k)-exempt, is that you can avoid getting FDA's opinion on this.
 

Enternationalist

Starting to get Involved
#17
@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.
In that case I honestly wouldn't even think about if it is technically required or not. If serious harm could occur as you say, I would perform testing as a matter of ethical obligation. Who cares if it's mandatory or not? Somebody could be exposed to serious harm, therefore we should do our due diligence in showing that the risks are acceptable.

I don't know enough (sadly) about your device, its marketing, nor the situation for 510(k) exempt devices to tell you meaningfully about the formal requirements .
 
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