Expert Warns of UDI Pitfalls, Advises Early Compliance
Devicemakers could spare themselves time and money by checking with UDI-issuing agencies to see if they have a current account before applying for new licenses, a former FDA official says.
Jay Crowley, who was instrumental in writing the FDA’s unique device identification rule, said most manufacturers have already done business with at least one of the three standards bodies approved by the FDA to issue UDIs: GS1, HIBCC and ICCBBA. Companies with established accounts can avoid increased licensing fees by using that account, rather than opening a new one, he said.
Crowley, who now heads up the UDI practice at USDM Life Sciences in Santa Barbara, Calif., spoke at the recent FDAnews Medical Devices Quality Conference in Bethesda, Md.
Determining whether a prior account exists is just one of the many last-minute details manufacturers must consider when implementing UDIs, which will appear on Class III devices in September and roll out to all devices over the next seven years. Crowley stressed that it’s highly unlikely the FDA will extend the compliance timeline.
Manufacturers could benefit from complying with UDI ahead of their deadline, said Steve Niedelman, lead quality and regulatory systems consultant at King & Spalding. For instance, UDIs will make performing and analyzing recalls easier and could become a selling point to customers who want to do their own internal inventory tracking. Devicemakers aren’t required to comply before the FDA deadlines, but may want to so as a customer-service step, he suggested.
Once UDI is imposed, expect FDA investigators to put it to work, Niedelman told conference-goers. “The FDA will use UDI labels to segue into design changes, design controls and labeling controls,” he said. “They’ll use it as a tool to drive through your quality system.”
Another concern to keep on the radar screen is verifying the bar codes used in UDIs, Crowley said. Companies are frequently lax about double checking bar codes for commercial use, but it becomes essential to ensure their readability when UDI is a factor, he added.
The Sept. 24 UDI deadline is right around the corner. Make sure you’re fully prepared by purchasing The FDAnews UDI Compliance Kit.