In 2007, Congress passed legislation directing the FDA to develop regulations surrounding a unique device identification system. An advance announcement of the final ruling was released Friday, September 20, 2013, at the UDI Conference in Baltimore, MD. Were you there? If you were, you saw flutes of champagne entering the conference room around 8:45am, as Jay Crowley, Senior Advisor for the FDA and UDI Regulation Lead, announced the final ruling. Of course, this is the FDA, so the champagne was apple juice, but the sentiment remained the same. Despite the many updates and extensions, many industry players inferred what the final ruling would entail, but Jay discussed some additional changes that may not have been anticipated. A few of the changes he identified are listed below, some of which have been markedly controversial.
- Standardize date format: Companies are required to comply with the new date requirement (YYYY-MM-DD), with the timeline corresponding with the device type
- UDI made simple: UDI must include the device identifier (DI), which is static, and the production identifier (PI), which is dynamic; hence, DI + PI = UDI
- Use of GMDN: A Global Medical Device Nomenclature (GMDN) must be obtained from the GMDN Agency
- Use of DUNS: A Data Universal Numbering System number will be required for UDI, as well as other FDA-regulated operations
Jay also touched on some noted exceptions:
- Class I devices: These devices do not need to include (dynamic) production identification
- Existing inventory: Companies have three years to use inventory of products that have already been labeled (this was a surprising – and significant – industry win)
- Individual single-use devices (SUDs): Exceptions for SUDs weren’t discussed at length in the proposed rulings, but the final rule now defines exceptions for each type of SUD
So the big question is – when does the timeline start? NOW. The timeline for implementation started on Tuesday, September 24, 2013, and follows the timeline in the proposed final ruling. The major timeline is below, but there are numerous possibilities for exceptions.
- Year 1: Class III devices
- Year 2: Class II/I implants and life-supporting/sustaining devices
- Year 3: Remainder of Class II devices
- Year 5: Class I
Obviously, there are many changes and new variables that must be reviewed and considered. While implementing UDI will require time and investment, if executed correctly it will add value to your products and services, and also provide value to your customers. Incorrect or inefficient implementations, however, can lead to slow or halted production, recalls on products that do no conform to regulations, and a drain on human or monetary resources.
For more detailed information on UDI and how it may affect your company, read our Insights paper, “Unique Device Identification: A Top 10 on How and Why to Implement UDI,” or review the final ruling. Ultimately, realizing UDI successfully will help ensure the health and safety of patients – and your business.