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Hi this is my first time posting thread on this website.
I found so many useful informations regarding FDA regulations from this website and I really appreciate all you guys inputs.
I am a regulatory specialist who works at Blood Glucose Monitoring System manufacturer.
We have devloped a website that the user can record their blood glucose test result and manage it.
The users can plug in their meters and the website can download their data from the meters. (Basically it is online version of logbook)
My question is Do I need to get 510k for this webisite?
I know that I need to get 510k for medical device related softwares.
If I do need to get 510k, what documentations do I need submit along the 510k? (since it is not for the device, I assume that no device description is needed)
Thank you guys in advance and I am looking forward some helps from you guys.
I found so many useful informations regarding FDA regulations from this website and I really appreciate all you guys inputs.
I am a regulatory specialist who works at Blood Glucose Monitoring System manufacturer.
We have devloped a website that the user can record their blood glucose test result and manage it.
The users can plug in their meters and the website can download their data from the meters. (Basically it is online version of logbook)
My question is Do I need to get 510k for this webisite?
I know that I need to get 510k for medical device related softwares.
If I do need to get 510k, what documentations do I need submit along the 510k? (since it is not for the device, I assume that no device description is needed)
Thank you guys in advance and I am looking forward some helps from you guys.
