For so many years, “soon” was the best answer the FDA’s point man on UDI – Jay Crowley – could say when asked when the final unique device identification (UDI) rule would be published. Today, on the final day of the UDI conference led by the FDA, Jay announced that advance notice of the final rule was published in the federal register, with the official publication expected next Monday or Tuesday. That’s when the clock starts ticking toward compliance dates for device manufacturers. And now “soon” could be too soon for those device manufacturers that have waited until now to starting thinking about how they will comply with the regulation. Very simply, the UDI rule requires manufacturers to assign and label their products with a unique device identifier and provide additional data on those products to a Global UDI database (GUDID). (By the way, FDA likes to pronounce GUDID as “good ID.”)
During yesterday’s UDI conference sessions, three major manufacturers: Johnson & Johnson, Medtronic, and Covidien discussed their UDI readiness efforts, some of which started in the 1980s. Granted, UDI compliance is more complicated for decentralized, multi-billion dollar, global organizations that frequently acquire and divests companies and have highly dynamic product catalogs. But UDI presents challenges, and opportunities, for companies of all sizes. Some companies, like Terumo and Teleflex as examples, have been working with GHX for some time on UDI readiness. Teleflex even presented its experience preparing for not only the rule, but also other customer and regulatory requirements for product data standards adoption, during the August Global Data Standards Users Group. You can access that recording here.
But judging by some of the questions at this week’s UDI conference, there are clearly many other companies that are just starting to think about UDI compliance. And those are the ones that were proactive enough to come to the conference.
Whether you have been working on UDI for years, or just getting started, my advice is to take a holistic approach. As Jay Crowley said this morning, “This is not about just being able to identify devices. We (FDA) are talking about a holistic approach to integrating medical device identification throughout the entire healthcare system. UDI will be a fundamental piece of everything we do going forward.” Case in point, the FDA plans to use UDI for a wide variety of purposes, well beyond what is included in the UDI rule. The UDI will eventually be incorporated into regulations around medical device reporting, recall authority, premarket approvals, and post market surveillance, just to name a few.
That’s why master data management is a key component of UDI readiness. And if done right, you can potentially minimize the time spent complying with other FDA regulations in the future. But as we have discussed in numerous other blog posts (search on UDI on the right side of the main Healthcare Hub page), locating, harvesting and aggregating the data required for the GUDID can be quite challenging. The data elements exist in a variety of places and formats, some not even electronic.
You can read about the data elements in the advance notice published today, and in the more concise formal publication next week. But for those that have been following the proposed regulation for some time, Jay Crowley provided an overview of what changed from the proposed to the final version. Here is a partial list of some of the items that suppliers have told us they are most interested in:
For more information on UDI readiness, contact Mike Gillespie at email@example.com. Next week, I am honored to have the opportunity to chair a two-day conference on UDI in Munich. Check the Healthcare Hub often for more on UDI in the US and abroad.