Unique Device Identification (UDI) will bring about a “huge global change” in the way medical devices are tracked and identified, Amy Fowler told MD&M Minneapolis conference attendees. Fowler, who serves as principal advisor, regulatory affairs, for RCRI, presented “UDI Draft Guidance on GUDID and Perspectives on Practical Implementation and Planning for Companies” on Monday, October 28.
MJ Wylie, senior director, healthcare, for GS1 US, later outlined how to employ GS1 standards when instituting UDI, speaking after Fowler in “The Next Steps in UDI Implementation.”
Fowler outlined the final UDI regulation and explained what will be expected of medical device companies over the multiple-year rollout. “Every medical device label must have a UDI, and every medical device package must have a UDI, but there are some exceptions,” she explained. If a company causes a label to be applied to a medical device with the intent to distribute comercially, that company must comply with the rule, she added.
Fowler also explained FDA’s draft guidance for the Global Unique Device Identification Database (GUDID), which was published September 24. She encouraged attendees to review the draft and submit comments to FDA before its 60-day comment period ends. Wylie later explained how companies could use GS1’s Global Data Synchronization Network (GDSN) to publish UDI data to the GUDID.
UDI is essentially “a reference number,” and with it FDA hopes to decrease medical errors and identify the devices associated with adverse events and recalls, Fowler explained. UDI will help users make “quick decisions” and answer questions such as whether a medical device is MRI compatible, she added. “And it will bring more efficiency to the system.”
UDI consists of a mandatory, static device identifier (DI) along with a conditional, variable production identifier (PI); the UDI must appear in plain human readable text and in automatic identification and data capture (AIDC) technology. A new UDI is required with every new version of a medical device and every new package, Fowler added.
Fowler explained that single-use devices (SUDs) packaged together and not intended for individual distribution do not need to carry UDI on their individual packages, just on the master package. And devices within kits bearing UDI have an exception where they will not be required to bear a UDI, she explained after the conference.
“Every company has to go through its product lines to see what exemptions apply,” she said.
Some of the more debated aspects of the UDI draft were changed in the final rule, such as date formatting and direct-part marking, Fowler said. “The standardized date format is now aligned with international standards: YYYY-MM-DD,” she said. “And direct part marking is not required for implants, but it is required for devices intended to be used over and over again and reprocessed.” Directly marked UDI can be identical or different from label UDI, and it can be text or AIDC or both, she explained. “And there are exceptions to direct part marking, if it interferes with safety or effectiveness or is not technically feasible.”
FDA can grant or rescind exceptions, and it will make those decisions available on its Web site. “Any labeler can use that exception, even competitors,” she said.
The rest of the world is following FDA’s UDI efforts closely, Fowler added. A common UDI “very similar to FDA’s UDI” was proposed in March 2013 and is expected to be adopted in 2014, followed by an implementation period, she said. And “Turkey has been a pioneer in requiring UDI,” she said.
Wylie explained how GS1’s Global Trade Item Number (GTIN) could be used for UDI. She then explained how the GDSN, which consists of multiple data pools around the world, is a “probable mechanism to publish UDI to the FDA GUDID,” adding that “the GDSN allows you to publish data once to FDA and to your customers.”
"As a summary UDI is about marking your products and submitting that to FDA,” Wylie added. In other words, medical device companies need to “mark labels with UDI, and submit the multiple required data attributes to the GUDID.”
UDI implementation deadlines are as follows: September 24, 2014, for Class III devices; Class II/I implants and life-supporting/sustaining September 24, 2015; the rest of Class II September 24, 2016; and finally Class I devices September 24, 2018.
Editor's note: This article was updated after posting on October 28, 2013.