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
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