FDA classification for a mobile app

Frank Katarow

Starting to get Involved
#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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Frank Katarow

Starting to get Involved
#2
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.
 
#3
Frank - most devices as such are classified as a Class IIa - however, the specifics of the device will determine this. With you mentioning that the risk is low - my initial thought is IIa
 

monoj mon

Trusted Information Resource
#4
Frank - most devices as such are classified as a Class IIa - however, the specifics of the device will determine this. With you mentioning that the risk is low - my initial thought is IIa
The original question was about FDA classification, not EU classification. There is no such a/b classification in FDA.
 
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