Hi All,

I would agree with the examples and the points given above. I believe that SR vs. NSR is really determined by a combination of the classification of the device and the application of the device. As was mentioned if a device is classified as a low class it may be a NSR. However if the device had an application that was more risky it may be then considered a SR.

However as was mentioned in the lecture, the sponsor makes the initial determination and then the decision is evaluated by the IRB, who makes the final decision.

-Andrew Nashed