The Office of Management and Budget has approved the FDA’s long-awaited universal device identifier (UDI) proposed rule, clearing it for release by the FDA. The FDA says the rule, once implemented, will provide the cornerstone for a modern postmarket device surveillance program.
First proposed in the FDA Amendments Act of 2007, each UDI will include a device identifier, which encodes the device model, as well as a production identifier, which includes the device’s batch or lot number and expiration date, if any.
The proposed rule requires the UDI appear on labeling and packaging for almost all devices within one year of the final rule’s implementation. They’ll then be placed on devices themselves over the next several years, appearing first on life-sustaining implantable devices in two years and then on almost all devices a year later. Class I and over-the-counter devices would be exempt.
The final rule is expected about six months after the comment period closes on Nov. 7, Shuren said. That would mean the requirement for UDIs on packaging is likely to kick in during the first half of 2014.
“Currently, some adverse event reports do not adequately identify the device,” said CDRH head Jeffrey Shuren during a July 3 conference call announcing the release of the proposed rule. He explained that even when reports include the name of the manufacturer and the kind of device, often it’s challenging to identify the exact device variety in question due to differences in lots or newer and older device generations.
Eventually, Shuren said, he hopes the FDA will be able to use UDI-reported data to spot problematic patterns before caregivers or manufacturers notice them, thereby reducing medical errors, speeding recalls and saving lives.
A UDI database pilot project will take place in August and September of this year, after which CDRH staff will use what they’ve learned to make any final tweaks, said Jay Crowley, senior advisor for Patient Safety at CDRH.
The rule was developed in consultation with the Global Harmonization Task Force (GHTF), in hopes of getting a worldwide UDI standard. The European Union, Brazil, Canada, Australia and Japan are part of GHTF, while Russia and China participate as observers.
The long delay in getting the UDI rule through the system had raised eyebrows on Capitol Hill and in the industry. Letters urging the release of the rule had been sent to the HHS Office of Management and Budget Director Jeffrey Zients from Sens. Herb Kohl (D-Wis.), Chuck Grassley (R-Iowa) and Richard Blumenthal (D-Conn.), as well as a coalition of healthcare organizations, and the prompt release of the bill was included as a requirement in the version of Medical Device User Fee Act legislation that passed through Congress last month.
The FDA spent $1.5 million to develop the UDI database, and expects the pilot testing to cost an additional $250,000, Crowley said. Costs to devicemakers are estimated at $68.4 million over the next 10 years.
AdvaMed Senior Executive Vice President Janet Trunzo issued a statement of conditional support for the UDI system, stating the group “will be paying particular attention to whether the proposed rule follows a risk-based and least burdensome approach” to implementation. “[S]uch an approach is essential given the huge diversity of medical devices and the cost and complexity of implementation,” she said.
Steven Niedelman, lead quality systems and compliance consultant at the law firm King & Spalding, said he anticipates some challenges in implementing the rule — for example, how do you print a code on tubing that may be cut to different lengths? — but few insoluble problems as devicemakers move to comply with the rule, especially because it’s been so long in the making. “Anybody who thought this wasn’t coming has had their head in the sand,” he said, pointing out that UDI discussions date back to 2007. “This is nothing new, and now it’s here.”
The proposed rule will be published in the July 10 Federal Register. Comments are due to docket no. FDA-2011-N-0090. View a prepublication draft at www.fdanews.com/ext/files/07-05-12-UDI-rule.pdf. — Elizabeth Orr
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