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Where can I get additional FDA information for In Vitro Diagnostic Device Labeling Guidance?

 

 
   

 

 

 

The FDA has a guidance on this:

In Vitro Diagnostic Device Labeling Guidance

Guidance on Labeling for Laboratory Tests; Draft
http://www.fda.gov/cdrh/ode/1352.html
http://www.fda.gov/cdrh/ode/1352.pdf

 

   
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