The Office of Management and Budget has approved the FDA's long-awaited proposed rule on a unique device identifier (UDI), clearing it for release by the agency. 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 that UDIs appear on labeling and packaging for the vast majority of devices within one year of the final rule's implementation. They'll then be placed on devices themselves, appearing on life-sustaining implantable devices two years after the rule takes effect and on most other 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. That means the requirement for UDIs on packaging, which takes effect one year after publication of the final rule, would kick in mid-2014.

“Currently, some adverse event reports do not adequately identify the device,” CDRH head Jeffrey Shuren said during a July 3 conference call announcing the July 10 release of the proposed rule. He noted that even when reports include the manufacturer and product names, it can be challenging to identify the exact device because of differences in lots or in newer and older device generations.

Shuren said he hopes the FDA eventually 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.

UDI Pilot Planned

A UDI database pilot project is slated for August and September, after which CDRH staff will use what they've learned to make final tweaks in the program, 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 U.S., European Union, Canada, Australia and Japan are founding members of the GHTF.

The long delay in getting the UDI rule through the system — from July 2011 to earlier this month — had raised eyebrows on Capitol Hill and in the industry. Letters urging release of the rule were sent to Office of Management and Budget Director Jeffrey Zients by 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 proposed rule was included as a requirement in the Medical Device User Fee Act legislation that Congress approved 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.

Industry Welcomes Rule's Release

AdvaMed Senior Executive Vice President Janet Trunzo issued a statement of conditional support for the UDI system, saying 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.

A UDI system will “ensure the integrity of products through the transportation process” and is “critical to the health of American patients,” said Curtis Rooney, president of the Healthcare Supply Chain Association, in praising the rule's release.

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?

Beyond that, he said few problems should be insoluble as devicemakers move to comply with the rule, especially since it's been so long in the making. “Anybody who thought this wasn't coming has had their head in the sand,” said Niedelman. UDI discussions date back to at least 2005. “This is nothing new, and now it's here.”

Comments on the proposed rule are due to docket no. FDA-2011-N-0090. — July 2012