It appears that the cloud is a part of your medical device, so yes, I would say you will have to describe it in your submission.
If however, the cloud is just a separate optional accessory (i.e. not required for functionality of your device) that allows the user to pass data to another system, then it might fall under the MDDS, which is now excluded from regulation.
In either case, don't forget to address cybersecurity requirements.
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Michael Zagorski RAC
Pittsburgh PA
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Original Message:
Sent: 30-Aug-2017 18:11
From: Bhupinder Singh
Subject: Cloud Computing for Digital Health Care
Hello,
We are working on a digital health care Class II device. Flow of data is from user the data goes to app, from app the data goes to our cloud. We are not making any analysis in our cloud.
Our cloud is only a pass through and the data goes to the third party cloud for analysis.
My question is this :
Does our cloud needs to be abide by FDA compliance rules and regulations?
Do we need to mention our cloud in 510(K) submission?
Thanks,
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Bhupinder Singh
San Jose CA
United States
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