FDA proposed labeling standalone software cloud based


Starting to get Involved
So, we are currently preparing a 510(k) submission for our medical device which is basically a stand-alone medical software cloud-based.

Our biggest issue at the moment is the proposed labeling - how to tackle it.
Obviously, some things are pretty much constant, like IFU, IU, directions for use, compliance with standards, standalone performance, clinical data, warnings, limitations, precautions, etc... However, we seem to be stuck there.

I'd really appreciate any kind of insight or feedback because it seems a bit trickier writing down the labeling for the standalone software than an actual hardware device.

Thanks in advance.



Starting to get Involved
Sorry for the long delay in getting you a response...

This *might* help: https://www.fda.gov/downloads/Medic...onandGuidance/GuidanceDocuments/UCM409401.pdf

There's a section on stand-alone software; obviously focused on UDI. What, specifically, are you struggling with?
No problem, any kind of help is appreciated, even if it is a bit delayed.
That one section on UDI is quite clear, but the problem is that I need more than that, to be specific, I need information what one User manual should contain when it comes to the stand-alone software which is cloud-based. Cautions, warnings, limitation, intended use/user/environment, indications for use... Any additional information?
Thanks in the advance. Cheers!
As yodon says, most of the warnings, cautions, etc. will derive from your risk management activities.

However, the FDA will also be comparing to your predicate device. Can you access their labelling? Unless justified otherwise, your labelling content will likely align with your predicate's. Also, you might survey other FDA-approved devices similar to yours (e.g. search within same product code), and see what approaches others have taken.

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