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Michael Causey

FDA Compliance

Medical Device Industry Identifies Problems with FDA’s UDI Initiative

Inconsistencies and hair-splitting with the term ‘required’

Published: Tuesday, January 21, 2014 - 12:14

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.

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concept, while finding lots and lots to say about where the U.S. Food and Drug Administration’s (FDA) September 2013 Draft Guidance could use improvement.

Noting that implementing UDI will be a “costly proposition,” AdvaMed stresses that the length and complexity of the implementation plan demands a “living document” approach that will allow industry and the FDA to update and improve the guidance as both sides learn more during setup. AdvaMed follows with 61 specific comments, with suggested changes.

Coviden, manufacturer of medical devices and medical supplies, echoes AdvaMed’s comments, and tosses another 22 comments into the mix, including a request that the guidance remain open for feedback and comment until the September 24, 2014, implementation deadline.

Merck, among other commenters, requested clarification and summarizing of the scope of products for which data must be submitted to the Global Unique Identification Database (GUDID). Merck also asked the FDA to add information regarding deadlines for submitting data to GUDID.

Boston Scientific, noting that its medical devices already bear unique identification via HIBCC or GS1 standards, calls the FDA out for what it labels “inconsistencies” with the FDA UDI Rule.

To pick one of their examples, and joining several other commenters in making this point, Boston Scientific claims the data-elements column titled “Required?” is unclear because it fails to clarify if it is required to follow the rule based on regulatory requirements or validation requirements. “The meaning of ‘required’ should be clarified so that both regulatory and system validation requirements are clearly identified in this guidance,” notes Boston Scientific.

The FDA has got its work cut out for it here, particularly with the recent departure of the agency’s UDI guru, Jay Crowley, for the greener fields of consultancy.

I can offer some small consolation, though: Crowley hosts a webinar on UDI implementation from his new professional perch at USDM Life Sciences. Information about the webinar can be found here.

First published Jan. 16, 2014, on the AssurX blog.

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About The Author

Michael Causey’s picture

Michael Causey

James Michael Causey’s been a journalist since he started his own neighborhood newspaper in the 1970s. In addition to quizzing FDA officials for the past 10+ years, he’s also interviewed political satirist Art Buchwald, FCC Chairman Reed Hundt, SEC Chairwoman Mary Schapiro, and is the past president of the Washington Independent Writers. Causey is the editor and publisher of eDataIntegrityReport.com and is a contributing writer on the AssurXblog.