New Establishment Registration and Device Listing Rule - August 2012

M

MIREGMGR

#31
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 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.
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.
 
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