Validating Software before getting approved as Class 2 device

#1
Hello everyone,
I'm new here and hoping you can help me to find the answer.
If the phone software can record the body sounds (like lung or heart sounds) and use them to detect diseases or symptoms, how can it be possible to offer this software to the users before it passes FDA approval? We need it to get people's feedback and do preliminary validation, we cannot afford to do a clinical validation at this stage yet. I searched that there are many phone software that detect disease from face pictures and they just use a disclaimer that they are not medical devices and not offering diagnosis. But since we collect the bio sounds from users, I have a concern that this can fall under different rules. I wonder if there is a solution to this.
Thank you very much for your answers!
 
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monoj mon

Quite Involved in Discussions
#2
I don't have any experience with SaMD, and will try to give my two cents based on my limited knowledge on SaMD.

I would like to know how you have classified your device as Class 2? Do you have any predicate device based on which you have decided that your device falls in that classification? If you have found any predicate then simply look into their 510(k) notification to check what type of testing they conducted.

If you don't have any predicate then I am afraid it would be considered as 'De Novo' by the FDA and may eventually require clinical evidence in your submission. Check the De Novo classification for the Apple ECG App. You better confirm it with FDA itself by requesting a Pre-Sub.

But if you are only concerned to conduct the 'usability' testing, then you could be able to provide the software to the users to record their feedback on 'usability' of the user interfaces.

However, looking at your question again and again, I assume that you are more concerned about the performance testing for the 'Safety and Effectiveness' of the device. For that, if you don't have any predicate to show equivalence and if you don't have a long history of safe usage to prove safety and effectiveness of the deice then you might end up with the De Novo classification and very unlikely that you would get clearance without clinical evidence.
 

Watchcat

Trusted Information Resource
#3
I do have some experience with SaMDs. IMO, you need a regulatory consultant. Now. I am of course biased, since I am one, but really, don't try to DIY this one.

You can offer it to users before it passes FDA approval, but then you'd probably be subject to all kinds of unpleasant FDA enforcement actions, so this course of action is not recommended.

PS Last I heard, FDA was just saying no to pre-subs. Maybe something to do with not having enough resources due to some pandemic or another. Also speculation that they had originally expected to be able to start charging user fees for pre-subs in October, but then MDUFA negotiations got pushed back, and they don't want to do them any more without getting paid.
 

Watchcat

Trusted Information Resource
#4
An update on pre-subs....

Graematter just reported 90- to 120-day delays. So apparently still happening...for some.
 

mihzago

Trusted Information Resource
#5
If you are looking to do some feasibility testing, and ask a few people to use it without providing the results to them, and without making any medical claims, and being clear that you’re just collecting data as proof of concept, and you don’t plan on using these results in the submission, then maybe there is a way. A more defensible way would be to obtain an IRB approval.

better yet, as Julie suggested, find a consultant you could ask for a more comprehensive advice.
 

yodon

Staff member
Super Moderator
#6
since we collect the bio sounds from users, I have a concern that this can fall under different rules.
Your concerns are well-founded. Patient privacy is a big deal these days and collecting protected health information, as you are suggesting, could get you into very hot water. I agree with @mihzago that you probably want to get more comprehensive advice from a regulatory expert. Expert advice here would well be worth the cost.
 
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