Embracing FDA UDI Ruling as a Strategic Opportunity

FDAlogo3We ran a post on Tuesday of this week (prior to this year’s 4th ) highlighting the significance of the FDA’s long awaited ruling on unique device identification/uniform device identifiers (UDIs). To be sure, for someone like myself who covers the entire healthcare industry, the announcement’s significance was not lost. I “get it.” But for companies fully dedicated to the supply chain management sector, the FDA’s announcement on Tuesday was truly a momentous occasion –and not one we’re going to overlook here at Healthcare Matters.

We will be running a series of guest posts over the next several weeks from the industry’s experts –those who have been living and breathing this long awaited FDA action. This afternoon’s guest post comes from Karen Conway, executive director of industry relations for GHX and author of The Healthcare Hub. Karen offers a candid warning to an industry that frankly, does not seem yet to fully comprehend what just happened.

Here’s Karen’s post:

The freedom we associate with our July 4th celebration has a new twist on it this year. We’ve been waiting 5 years for the FDA UDI rule and we finally got it on the 3rd.  The proposed rule – requiring medical devices distributed in the United States to carry a unique device identifier, or UDI- was finally issued and will be posted in the Federal Register within the week.  That’s when the clock starts ticking, especially in light of language included in the FDA Safety and Innovation Act (aka the FDA user fee bill) passed by Congress in a rare display of bipartisanship.

The user fee act calls for the final rule to be issued no later than six months after close of the comment period – which will be 120 days according to the proposed rule. That means, it will likely be out by May of 2013. The user fee act also calls for implantable devices to bear the unique identifiers within 2 years after the final rule is published, but the proposed rule moves the timeline for Class III devices, which includes implantables, up to 1 year after the final rule comes out, or as early as May 2014.

This should serve as a wake-up call for medical device manufacturers that it’s time to prepare.  I continue to be astonished at the lack of widespread awareness of the pending regulation among many manufacturer representatives, especially given that language calling for creation of a UDI system was included in the FDA Amendment Acts of 2007.  Last month, I spoke at a conference for orthopedic device manufacturers and asked those in the audience –from manufacturers large and small – who had heard of UDI.  Only one person raised his hand.

While compliance is still a couple years away, there’s a lot to do, especially for global implantable device manufacturers with extensive product lines and multiple production lines.   Not only do they need to make sure each of those lines can accommodate both static and dynamic data for labeling their products, they are likely to be faced with different UDI regulations in the various countries in which they are market their products.  Regulators around the world have been watching what the US FDA does and many plan to follow suit.

I encourage suppliers to approach UDI and product standardization as a strategy, and not just check the regulatory box.  While the FDA’s primary intent is to improve patient safety, use of unique identifiers can deliver a myriad of other benefits, from more streamlined and accurate supply chain operations to better customer service.  By looking at all of the potential benefits and adopting a more holistic approach to the UDI, manufacturers can realize a greater return on what will be a required investment.

Hospitals and other healthcare delivery organizations, too, should pay attention and being thinking about how they will capture and use the identifiers in the future.  After all, if they don’t use the identifiers, much of the intended value of UDI will be lost.  There are a number of benefits they can realized through voluntary adoption (from recall management to clinical documentation of products used in patient care), but there is talk in Washington, DC of requiring usage of the unique identifiers by providers in the future.

Thanks again to Karen Conway of GHX

—Tom Finn


  • Robert Fickling:


    Thanks for this thread on UDI. As a supplier of thermal transfer products to the medical device industry, I have seen the interest in this idea in Europe move from concept to application. I have been following this FDA initiative here in the US. This is helpful, Thank You

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