FDA Preps for Unique Device IDs
BY LAUREN UZDIENSKI, JUNE 6, 2007
At MDMA's annual meeting, CDRH's Director of the Office of Science and Engineering, Dr. Larry Kessler, discussed FDA's goals for unique device identification and a multi-phase plan for establishing and implementing a UDI system. The talk followed bipartisan support for a UDI system from Congress, an effort spearheaded by Reps. Mike Doyle (D-PA) and Pete Sessions (R-TX).
In his presentation, Dr. Kessler highlighted benefits of a UDI system, among them: reducing errors by identifying issues with compatibility and interoperability and improving identification of a particular device for adverse event reports and recalls. He outlined the process for adopting the system, including the daunting task of creating and implementing a database that would track devices over their lifespan. Questions that remain include how to deter counterfeiting and how to tag combination products and reprocessed devices.
As FDA moves ahead with plans for the UDI system, their efforts now are focused on refining an approach. The agency is currently evaluating comments from last fall's Federal Register Notice and public meeting, determining FDA's role in the system and assembling data on costs and benefits of the program.
Despite earlier resistance to a mandatory system from MDMA and others, a national UDI system seems to be a matter of when, not if. No timeline was given, and it seems that many of the specifics are still to be determined, but we can assume that industry should anticipate a universal UDI system in the near future.
