Research Use Only Medical Device - Standalone software product

robert.beck

Involved In Discussions
#11
Thanks for the response. To clarify, the device is a class 2 device that has a 510(k) clearance. it's definitely not an IVD. It's a device that has a diagnostic use. If the company decides in the future to market the modified device, then the company will follow the process for determining whether a new 510(k) needs to be followed. However, at this time the modified version is meant to be used for research purposes. the modification is being made at the request of a research institution that wants to study some specific patient characteristics in conjunction with the use of the device. I don't know if there will be a formal study with a protocol, and the company will make only one device at this time. there will be IRB approval of the device use.
 
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sreenu927

Quite Involved in Discussions
#12
From my view, a medical device may be used for research purposes and NOT vice-versa; applicable, if the SW allows to do so and has the functionality to switch. This is because, medical device regulations are higher than research use only regulations.

Regards,
Sreenu
 

robert.beck

Involved In Discussions
#13
thanks again. however it is not software it seems that this post has gotten into a software discussion. I've looked at the regulation about IVDs and I wonder if you or anyone else can point me to the comparable regulation for devices. The device does not require clinical data to be approved/cleared, so I don't think an IDE would be needed. However, I don't know for sure about:

- exact labeling.
- informed consent.
- IRB/ethics committee approval.

this device does not
 
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