The Healthcare Hub

Getting Ready for UDI: The Clock is Ticking

Wednesday, July 11, 2012

There was more movement in Washington this week related to the pending regulation requiring unique device identification (UDI) of medical devices. Yesterday, the proposed UDI rule, along with all the references and attachments, was published in the Federal Register, which starts the clock ticking on the 120 days during which interested parties can provide comments on the proposed rule. At the end of that comment period, the FDA has six months to publish the final rule, under a deadline included in the FDA Safety and Innovation Act (aka the FDA user fee act), which the President signed this week. 

There’s an additional opportunity to comment – in a much shorter time frame, 60 days- on some standard but specific questions asked by the White House and the Office of Management and Budget related to the Paperwork Reduction Act. Those questions are included in the proposed rule, but are also listed below:

  1. Whether the proposed collection of information is necessary for the proper performance of FDA's functions, including whether the information will have practical utility;
  2. The accuracy of FDA's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;
  3. Ways to enhance the quality, utility, and clarity of the information to be collected; and 
  4. Ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology.

Although the big questions about timing of the rule are being answered, there are many other issues that still need to be addressed. One of the biggest is which products will be impacted first. The proposed rule is relatively clear; it takes a risk-based approach and focuses first on Class III products, which includes many of the implantable devices. If the timeline in the proposed rule stands, they would need to bear the unique identifiers a year after the final rule is issued (or likely by May 2014), with the deadline for Class II devices two years later and Class I products four years later.

But the FDA user fee act creates some confusion, with language stating that “devices that are implantable, life-saving, and life sustaining” need to be in compliance “not later than 2 years after the regulations are finalized.” Since there are non-Class III products that meet this broader definition, the FDA is busy working to provider further clarification.

This question will undoubtedly come up next week, when Jay Crowley, Sr. Adviser for Patient Safety with the FDA’s Center for Devices and Radiological Health, and the FDA’s primary point person on UDI, will be the guest speaker for the GHX Global Data Standards Users Group monthly call. If you are interested in participating in the call, send me an email at

Tomorrow, the Healthcare Hub blog will feature a guest blog from Mike Gillespie with GHX Business Solutions. Mike has been consulting suppliers on how best to prepare for UDI, not only in the US but also in other parts of the world considering similar regulations. On that note, I also heard today that the European Commission has begun circulating – albeit on a limited basis – a draft document with its recommendations for a common framework for UDI in the European Union. That regulation could be out as early as next year.

In this this multi-part series, we will continue to keep you posted on new developments related to UDI regulations. Next week, we will focus on what providers can and should be doing to get ready for UDI, including updates on the relationship of UDI to meaningful use of electronic medical records and to quality measures currently in development.

If you have questions or topics you would like us to cover related to UDI in The Healthcare Hub, send me a comment. 

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Karen Conway

Vice President, Healthcare Value