Changes to device that is now 510(k) exempt

K

KTompkins

#1
Our company has a Class II device that received a 510(k) SE determination in 1994. The device is now exempt per the Food and Drug Administration Modernization Act of 1997. We now are looking at making changes to that device.

Do we have to update the 510(k) at any point, or do we simply have to document internally as normal for the DHF?
 
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G

gar4guv

#2
If you're sure that the device is exempt from the premarket notification requirement, and that any changes do not alter the intended use (thereby possibly changing the classification of the device), then you should be fine just keeping documentation in the design history file.
 
K

KTompkins

#3
I know for sure that it is exempt, and indications for use have not changed. Just wanted to make sure I wasn't missing anything.

Thank you!
 
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