GS1 and FDA Shine At The FDA's UDI Meeting Last Weekby Enterprise Labeling on Feb 19, 2009 • 6:47 pm No Comments
Loftware was invited to and attended last week’s official gathering for the FDA UDI initiative. We listened to a lot of our customers — most every major player there is a customer — and others talk about the FDA’s position and what these various folks think the FDA should do.
It really was a meeting of who’s who in the medical and device world. We learned a lot. We also saw that a lot of companies are very concerned about what the FDA might do and when they might do it.
On a related barcode standards note, GS1 had an amazing presence, demonstrating a global depth of bench and experience spanning decades, languages and countries. It really drove home the global dominance of GS1.
I was most impressed at the end of the day, however, by Mr. Jay Crowley of the FDA. Loftware has been participating with various GS1 committees — GTIN, GLN, GDSN — for awhile now and Jay Crowley, the point man for the FDA on the UDI initiative, has been in most of those meetings as well. Even-handed, sensible, careful in manner and speech, he has deftly traversed topics where people really, really want to know what he thinks (and would love to know what the FDA plans on doing). He is, needless to say, a very popular guy with anyone who is concerned with the FDA’s views on UDI.
This was all the clearer at this meeting where Jay was frequently asked direct, sometimes blunt, questions and given direct, sometimes blunt, comments on what the FDA will do, should do, shouldn’t do and when. He handled it all with aplomb and conveyed to all of us, I believe, that the FDA listened openly to everyone’s input and nothing was dismissed out of hand. It was an amazing and amazingly open air meeting.
If it’s any indication of the sagacity of what’s coming from the FDA on UDI, while it’s clear not everyone will be happy with it, I think the FDA is going to shine on its implementation of the Congressional mandate on UDI.
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