FDA Product Classification - Self Treatment Software Applications

#1
Hello,

I have a software application (can run on PC or anywhere) for which I am trying to find a product code & regulation number. It is class I CE marked.
The software asks a patient questions, then proposes a self-treatment plan for the patient to try resolve the symptoms, otherwise they need to see a specialist physician. The treatments are low risk such as using ointment, washouts etc - self administered. All low risk, no potential of injury.
In effect it is decision support software. The only decision support search result is for burns treatment - regulation no 868.1890.

Any suggestions on search techniques ? I've been through all the software classification guidance with no luck. Seems I may need a 513(g) application ?

Thanks
Brian
 
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mihzago

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#2
what conditions are you diagnosing or advising on?

consider not only the risk of "treatments" you are proposing, but the risk of complications or not recommending getting treatment by an HCP.
 
#3
Thanks mihzago - it is in opthalmology, so risks of complications or no treatment are not much more than irritation / discomfort - no clinical risk.

I've noted that some software devices are accessories to specific equipment, so classification is linked to a panel....
 

mihzago

Trusted Information Resource
#4
opthalmology is a pretty big field.
if I lose my eye, that's more than a discomfort.

what is your intended use and indications for use?
 
#5
unfortunately I can't go into more detail ! - but no possible injury !

Point is - nothing close in terms of product code ? I've even looked through the entire opthalmic listing...
 
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