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In looking back at this thread this morning to see Sreenu's response regarding GPLE, I realized that I left out part of the answer in my post above about the component-device boundary.
I should have said: if the object either has patient contact or substantially determines the overall device/system's safety or efficacy, the object may be a device; and if FDA has defined a Product Code for the object, even if you might otherwise think it's only a component, it probably is a device. Otherwise it's not.
I think the decision-basis historically has been: if the object either has patient contact or substantially determines the overall device/system's safety or efficacy, the object may be a device. Otherwise it's not.
Of course, you have to start any such determination by searching the Product Code database to see if your object appears there in some manner.
Of course, you have to start any such determination by searching the Product Code database to see if your object appears there in some manner.