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  UDI Direct Marking Final Guidance

On November 17, 2017 FDA-CDRH issued the final guidance document on Unique Device Identification direct marking. The final guidance replaces a draft issued on June 26, 2015.

 

The UDI final rule created the system of direct marking. The final guidance provides additional details for the rules implementation. In particular, the guidance document provides definitions of some terms that apply to UDI direct marking including “intended to be used more than once” and “intended to be reprocessed”.

 

 

 
 
 
 
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