A September 24 deadline set by the Food and Drug Administration is looming for Class II medical devices, such as condoms or wheelchairs, to be outfitted with unique device identifier (UDI) barcodes, but in a survey of device makers, only a few said their companies were currently compliant with the standard.
The survey from labeling solutions company Loftware and USDM Life Sciences involved 120 “medical device industry professionals responsible for regulatory, IT and labeling.” 93 percent of respondents said UDI standards have impacted their business. When asked if their companies are currently compliant with the UDI requirements for Class II medical devices, only 15 percent said yes, even though the deadline for compliance is less than two months away.
“Many device manufacturers are struggling to meet the FDA UDI compliance timelines – however, the overriding issue to UDI compliance is in developing and implementing a sustainable, extendable UDI program and understanding that UDI is and will be a constantly growing and evolving process, said Jay Crowley,USDM Life Sciences Vice President of UDI Services and Solutions. “As new products come on to the market and as new needs arise we need to continue to evolve how we identify medical device and document the metadata associated with them.”
When asked about their biggest challenges with UDI compliance, 50 percent said it was getting all the necessary data on the label, 45 percent said it was pulling labeling data from enterprise applications, and 36 percent said it was understanding and applying the UDI regulations.
The FDA issued its finalized rule on implementing UDI standards in Sept. 2013, with the requirements being phased in over seven years. Since then, the agency has issued several guidance documents outlining how device makers can meet the new standards, most recently on the form and content of the label.
Delaying the September 24 deadline, however, doesn’t appear to be an option for the FDA.
“The FDA believes the phased implementation schedule outlined in the final UDI Rule gives labelers of class II devices adequate time to comply with the applicable UDI requirements by September 24, 2016. We expect class II labelers to be making diligent efforts to fulfill their UDI obligations,” the agency said.
Individual device makers can ask for time extensions, but those requests have to be filed with the FDA by August 24.