FDA classification for a mobile app

#1
We currently have a class II medical device. The device collects date which is then uploaded to a cloud server using a PC whare its is accessed by clinicians.
Question is if we were to create and app and upload the same dats to the server via a cell connection what type of regulatory would be required?
 
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#2
Without getting into the details of the device and its potential risk for safety and efficacy, it's difficult to say definitively. However, based on the fact that have an existing 510k predicate device, I would guess that you would have a good chance for clearance of your new device as Class II as well. You should look up similar devices based on apps uploading data as predicates and include them as predicates in your submission. Sound like a straight-forward submission, but you never know until you get into the weeds. Best to schedule a pre-sub meeting w/ FDA.
 
#3
Thank you for your reply. The device is a simple data recorder. There would be no safety issue that using an app would create. All the app does is pull the data from the recorder after it has been collected and and pushes it to a cloud server. Really just replaces the PC application that does the same.

Sounds like a class II 510k is the answer.
 
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