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Medical Device Industry Identifies Problems with FDA’s UDI Initiative

Inconsistencies and hair-splitting with the term ‘required’

Michael Causey
Tue, 01/21/2014 - 12:14
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Let’s start with what most everyone agrees on: The Unique Device Identification (UDI) program is a swell idea. It gets a little trickier after that.

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In extensive comments, the Advanced Medical Technology Association (AdvaMed), Boston Scientific, and Merck, among more than a dozen other stakeholders, generally voice support for the UDI concept, while finding lots and lots to say about where the U.S. Food and Drug Administration’s (FDA) September 2013 Draft Guidance could use improvement.

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