FDA to Industry: Don't Wait for the UDI Rule, Start Implementing Now

By Daniel R. Matlis

Earlier this month, I had the opportunity to attend the UDI Conference in Baltimore, MD. The conference was chaired by Jay Crowley, Senior Advisor for Patient Safety at the FDA’s Center for Devices and Radiological Health. During the conference, Mr. Crowley announced that the agency would not release the Unique Device Identification (UDI) rule before the end of the year. Instead, the rule is expected to be available for comment late in the first quarter of 2011, and the Final rule issued by the end of 2011. Implementation of the rule will be phased-in based on the device’s classification. Class III devices (the highest in risk and fewest in numbers) will be required to bear UDI within 12 months of implementation, while Class I devices (the lowest in risk) will have up to 60 months to implement UDI.

Mr. Crowley’s message to Industry, however, was clear: “Don’t wait for the UDI rule, start implementing now.”

FDA’s Unique Device Identification (UDI) System is expected to standardize the disparate medical identification methods in use by different Healthcare stakeholders today into a single device identification system that is consistent, unambiguous, standardized, and globally harmonized. Achieving this goal will require the collaboration of all constituents in the medical device ecosystem. According to Mr. Crowley, “there are many business benefits to UDI like systems, but everyone in the supply chain must commit to using UDI to achieve them.”

The announced delay in the implementation of the UDI regulation had the typical reaction from Industry constituents. Large Medical Manufacturers, including Becton Dickinson, Covidien and Johnson & Johnson presented their UDI programs and encouraged others to move forward with UDI implementation. On the other hand, many of the smaller manufacturers and the makers of Class I devices that I spoke to commented that this delay would provide management with the justification to push off implementation of UDI into the next 5-year planning cycle.

During lunch, I had the opportunity to chat with many members of the FDA UDI team. In our conversation, one of the FDA team members posed a question that illustrates the different perspectives between Regulators and Industry. “If industry has known that the rule is coming since 2007 (Food and Drug Administration Amendments Act of 2007 Sec. 226 included provisions requiring the establishment of a Unique Device Identification System), why haven’t companies already implemented systems to support UDI? In other words, why wait to for the rule; should not industry implement these systems well in advance to be ready to comply once the rule is promulgated? It is a bit of a chicken and egg situation, I explained. Regulators would prefer that Manufacturers have systems in place as soon as the final rule is implemented, but manufacturers want to know what is in the rule before implementing systems and processes needed to support the rule. Waiting for the rule avoids false starts, the high costs associated with changes, and retrofits to large system (like ERP) needed to support the UDI rule.

This is especially significant in light of the fact that, according to FDA sources, the preamble to the UDI rule is expected to span 300 pages, while the regulation itself should weigh in at around 60 pages.

Given the significant benefits UDI could have on to public health, the early implementation of systems supporting UDI seems to outweigh the risks. The Global Harmonization Task Force (GHTF) provides a path to early implementation while minimizing the cost of false starts. GHTF has recently published for comment its draft guidance on Unique Device Identification (UDI) System for Medical Devices. The GHTF UDI document provides what many consider the cliff notes for the upcoming UDI Rule, at only 24 pages including the preamble.

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