The good news is that the agency appears willing to listen to all stakeholders on how best to write the requirement. It published a notice in the August 11, 2006, Federal Register seeking information about “the feasibility, utility, benefits, and costs associated with the development and implementation of a UDI system.” The full text of the notice can be seen at www.fda.gov/OHRMS/DOCKETS/98fr/06n-0292-n000001.pdf.
FDA mandated bar codes for drugs and biologics in 2004, but it did not extend the provision to devices after industry convinced it that implementing a standardized identification system for devices would be too difficult.
But that was before the uproar over safety issues involving implantable cardioverter-defibrillators and other devices. In today's political and regulatory climate, FDA is simply not going to retreat from any idea that it believes will improve patient safety.
However, this does not mean that industry should resign itself to being faced with a burdensome, ill-fitting regulation.
Back when the requirement for drugs and biologics was being drafted, I was following the issue very closely. At the time I was on the staff of MD&DI's sister publication, Pharmaceutical & Medical Packaging News. I remember when the agency's first draft came out and the drug industry went ballistic. It was clear that the agency knew very little about bar codes, much less other identification systems, and that it had no idea how to feasibly integrate them on drug packages.
But meeting after meeting was held, public comments piled up, and gradually agency personnel were educated about the technology. The final rule that resulted was not perfect, but it's something that everyone seems to be able to live with.
These days, the agency is much more knowledgeable about identification technology, and, one would think, has a much better sense of what systems will and will not work.
Encouragingly, the agency appears to be willing to keep learning. The notice includes 20 specific questions on which FDA wants input from industry and other stakeholders. These questions range from whether UDI should be applied to all devices or just some, what level of packaging should the UDI be on, and what data sets are appropriate.
AdvaMed appears eager to engage FDA, and a healthy dialogue should ensue. The organization would like to see any UDI rules be made voluntary but also wants the agency to ensure that unrealistic and inappropriate provisions are not imposed.
“We are encouraged that FDA is taking a methodical approach to exploring the feasibility and utility of a unique identifier system for medical devices and that the agency recognizes the breadth and diversity of medical technology products,” says AdvaMed president Stephen Ubl. “Devices are extremely variable in size, shape, and materials—from tiny implants to room-sized imaging systems—and do not lend themselves to a single method of identification. The medical technology industry recognizes the utility of unique identifiers, such as bar codes and other automatic identification technologies. Industry recognizes the benefit of and supports the development of standardized Auto-ID rules with common data elements. However, given the range of medical devices, we continue to believe adoption of any standardized rules should be voluntary.”
This is a fine first step, but industry now needs to provide details about what a reasonable UDI system should look like, because UDI is probably here to stay.
Comments are due in early November and can be submitted electronically to www.fda.gov/ dockets/ecomments. Make sure to reference Docket No. 2006N–0292.
Erik Swain for the Editors