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What is an FDA Product code & why is it required?

On 29th December 2016 The U.S Food Drug Administration implemented its Final Rule with regard to ACE (Automated Commercial Environment) submissions; ACE being the U.S, single-window clearance application. Additional information requirements have been made mandatory and entry cannot be made without all data elements being in place.

This below document sets to highlight information provided within FDA Guidance in relation to Medical Devices, Biologics and Drugs (Human Use)

Click here to view the document.

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