|Under the FDA's newly enacted UDI rule, devices must be shipped with a unique identification label. (Click to expand.)--Courtesy of the FDA|
"Mr. UDI" gave industry advice on complying with the complex unique device identification rules as medical device companies barrel toward the Sept. 24 UDI deadline for high-risk devices. Former FDA official Jay Crowley has acquired the nickname for his role in implementing and designing the UDI system. He is now a consultant for USDM Life Sciences.
Out of all the compliance aspects, The Global UDI Database (GUDID) is causing the most angst among manufacturers, "for a host of reasons, not the least of which is that often the data required to be submitted doesn't actually exist," Crowley said in a podcast with "The Silver Sheet". "You have to often comb through other databases to find the information that's needed, whether it's a premarket submission number or a listing number.
"It's critical that you come up with a good process for doing this. Make sure that you understand how each of the data attributes are defined and the rules around them. Make sure that you come with a consistent approach for filling in each of the data attributes," Crowley said, adding that it's important to verify and validate the data that's submitted to the GUDID.
For example, barcode verification is essential. Simply making sure that the barcode is scannable is not sufficient. "What verification does is assess the quality of the barcode," he said. Unfortunately, many companies have learned that their printers or printer heads do not produce barcodes that are up to snuff with the regulation's quality standard. Crowley advised having barcode verifiers and a barcode verification plan in place "to assure that the barcode you producing can actually be read by a whole host of scanners down the line."
At a more basic level, Crowley said many companies still believe that the identifier should be applied on sales or distribution units. "Although that may also be true, we find that typically packages within the sales unit or distribution unit also require a UDI," he said. In other words, UDIs are required at the unit of customer use or on the individual device itself, with some exceptions.
"The other issue that we've seen is really around documenting well your thought process in terms of how UDI is applied," he said, noting that the use of exceptions must be justified and shown to be in accordance with FDA guidelines.
Europe and even China are working towards implementing UDI as well. Crowley said companies should keep an eye on global harmonization of the system and be aware of subtle differences in rules between countries and continents.
By Sept. 24 the labeling, date format and GUDID requirements must be met for high-risk devices, and the direct mark deadline follows in September 2015. Low and moderate risk devices must meet their own set of deadlines as well.
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