In Reply to Parent Post by kakoni
There is this device company called glooko that makes special cable for iphone that can be used to sync data from blood glucose meters into their iphone app.
To me it seems that this system is not classified as medical device(=Understandable, but when reading mdd it seems that this would fell into i/iia category).
So I guess my question goes;
- How are these 3rd party enablers (like in this case communication enabler between iphone and bg meter) seen in the regulatory world?
A device is a medical device if the manufacturer so intends ...
So glooko is making it for the iphone guy or the bg meter guy ?
If the bg meter guy, then its an accessory for his medical device and can so be classified.
So, Mr kakoni, welcome to the cove and tell us if you represent glooko, or the iphone company or the bg meter company.