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  Article on Risk Based Inspections added to the Ombu Library

The FDA Reauthorization Act of 2017, FDARA, changed the basis for scheduling device inspection. The law has shifted from a calendar basis, once in every two years, to a risk-based schedule. The Ombu Library, in the FDA Information aisle, has an article that explains the change and describes the risk factors.

 

 

 
 
 
 
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