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Wednesday, September 08, 2010 12:01 AM

Devine Guidance: Labeling and Packaging Control

Let Dr. D begin this edition of DG by stating that labeling and what constitutes being a label can be confusing for device manufacturers. Labeling collectively consists of multiple components, depending on the device manufacturer’s packaging configuration. As a minimum, labeling comprises of the outer-most label on a packaged device, the Instructions for Use (IFU), information imbedded into the artwork on a carton or pouch, a pouch label, or even something as benign as a flash labe more...

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