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The United States Food and Drug Administration issued a final rule regarding Unique Device Identification System (UDI) on September 24, 2013.  This rule requires medical device manufacturers to label product including a UDI as early as September 24, 2014.  The rule has various implications on regulations 21 CFR 801.3, 803.3, 806.2, 810.2, 814.3, 820.3, 821, 822.3, as well as part 830.

This white paper distills the rule into an easy to read format, highlighting critical dates and corresponding medical device products, as well as laying out a simple path to follow in order to comply. With links to the FDA rule, notes, comments, guidelines, and exceptions, the white paper provides a concise roadmap for implementation of UDI.

 

Get VIA's FDA UDI Mandate - In a Nutshell white paper.
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