Split an App into MD and NMD

[MED_men]

Hello fellow colleagues!

Long story short: imagine you want to control remotely your medical device (FDA class II) using an app in your smartphone.
Note this will be the only way of controlling the device (so no buttons on the device itself).

When developing the app, there will be SW features considered as medical (like the control of the device), and others as non-medical (like user statistics recording).

1st question: the best approach is to consider the app as an accessory in the full 510k? or as a system component?
2nd question: can we separate the SW architecture efficiently so that the 510k will only refer the medical functions of the app?
3rd question: if 2nd question is true, what real differences shall we expect from both documentation and SW development perspective? Meaning will it be easier to consider the whole app as a medical app, or split it into like 10%MD + 90%NMD?

Very grateful for your feedback

 

[yodon]

I don't think you'll be able to consider a single app being both a medical device and a non-medical device. I don't think it will be considered an accessory since you actually control the device with the app. (To me, that doesn't fit the "support, supplement, and/or augment" criteria.)

You probably want to take a look at IEC 62304 (medical device software lifecycle) - it's a recognized consensus standard by the FDA. You *might* be able to architect the system to assign a lower safety class to what you're referring to as the non-medical part (and thus reduce the documentation burden).

 

[mihzago]

You actually can divide SaMD into medical and non-medical functions and FDA has a guidance document for it.
Multiple Function Device Products: Policy and Considerations

It's a little convoluted and there's some critique that FDA muddled the difference between a function and a hardware component; in my opinion, because it's just another way for them to ask for more data.

I would probably consider your app as a component because I don't see advantage of having it separate as an accessory. You're not going to get a separate clearance for it and probably not selling it separately for use with other systems.