Classification of a cloud- base viewer for the output from a medical device

shimonv

Trusted Information Resource
#1
Hi Fellows,
Suppose a company developer a cloud-based app for a physician to be able to view data generated by medical device and transmitted by the cellphone to the cloud.
This app does not perform any processing, measurement, tags, etc. Just a "dumb" remote viewer.

Does that constitutes a medical device? I think not, but would appreciate your input on this subject.

Thanks,
Shimon
 

mihzago

Trusted Information Resource
#5
how are data presented? Does it just display the output collected/calculated by the device, or does it present/manipulate the data in some fashion, e.g. trending, highlight values based on thresholds, etc.?

If it's just raw data generated by the device, then the cloud-based app seems to be MDDS, which is no longer regulated.

If it does some data manipulation, then depending on the nature of the data, it could fall under CDS.
 

Watchcat

Trusted Information Resource
#6
As always, it depends on the jurisdiction. For FDA, I'm pretty sure it is a medical device,, but you should take a look at the tortured history of FDA oversight (or not) of medical device data systems (MDDS).

PS If your client happens to be in the US, I may have told them that already. :giggle:
 

shimonv

Trusted Information Resource
#7
how are data presented? Does it just display the output collected/calculated by the device, or does it present/manipulate the data in some fashion, e.g. trending, highlight values based on thresholds, etc.?

If it's just raw data generated by the device, then the cloud-based app seems to be MDDS, which is no longer regulated.

If it does some data manipulation, then depending on the nature of the data, it could fall under CDS.
Thank mihzago. Just to clarify, by "raw data" you mean unprocessed or presenting clinical data just as it is received.
I did see that the FDA guidance on CDS is still in a draft state. I guess I need to find some slides from an FDA presentation or something to better figure out what is their current thinking.
 

Ed Panek

QA RA Small Med Dev Company
Trusted Information Resource
#8
Currently explaining a group of new viewers including a cloud version to FDA that were previously limited to smart devices; now we have a cloud interface to view data on a web portal. Questions from FDA were around the presentation of data, and why we needed a new web portal. Explanation was all have the same data but some users prefer to see them in advanced configurations (Clinical users). Aside from being confused originally, FDA seemed ok after our call today.
 
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