UDI Compliance: Deadlines Depend on Device Class
by Laura Johnson, on May 15, 2017
Compliance with the Food and Drug Administration's Unique Device Identification (UDI) system will be vital for medical device manufacturers in the years ahead. The deadlines for implementing the related labeling and tracking rules are therefore essential knowledge for leaders in the field. Those dates have shifted over the past few years and depend on the type of assets being created.
Watching Deadline Changes
As Med Device Online indicated late last year, there have been a host of changes to UDI implementation deadlines since the regulations were finalized in 2013. Those changes included pushing the mandatory removal of previous identifying information to 2021, as well as setting the general UDI implementation date for non-implanted, non-lifesaving and non-life-supporting devices to September 24, 2018, two years later than initially slated.
The process of creating a universal data registry - and the need for manufacturers to comply with it - has reached European shores, as well. Med Device Online noted that amid the rollout of the U.S. system and the ever-shifting deadlines, government agencies are working with their EU counterparts to determine the best course to take for UDI implementation in those countries.
Specific Exceptions are Possible
Some medical device types are being held to UDI labeling compliance dates separate from the industrywide defaults. As the Regulatory Affairs Professional Society recently noted, contact lenses are one such example. Soft contact lenses have been granted a third extension to UDI compliance deadlines.
The FDA is in the process of developing an information submission system that can handle DI for contact lenses. Once that technical process is complete, the FDA will contact affected labelers on new procedures and release the relevant updates. This internal FDA work has pushed back the compliance deadline. Extensions expire on September 24, 2017.
Progress Can't Stop
Medical device manufacturers are in a tricky position today. They need to keep a close eye on compliance deadlines for information submission and labeling, but they can't stop producing new items and improving their internal processes. The agility granted by a modern standardized barcode labeling solution will be welcome, giving companies a better way to keep records accurate and centralized.
Even with UDI deadlines moving back, manufacturers can't afford to let them slip their minds. Companies heading for the 2018 date must make progress toward full supply chain visibility while obeying the everyday need to keep production efficient. Effective barcode labeling software will make this goal surmountable.
For more information on labeling in the Medical Device space check out our Q&A report on that topic.