FDA Issues Final Rule for UDI System

On Friday, Sept. 20, the U.S. Food and Drug Administration (FDA) announced a final rule for the long-awaited unique device identification (UDI) system.

Once implemented, the system, according to the agency, will provide a consistent way to identify medical devices.

The UDI system is designed to improve the quality of information in medical device adverse events reports, which will help industry and the FDA identify product problems more quickly, better target recalls and improve patient safety. Years in the making, the development of the UDI system involved collaboration among FDA, the medical device industry, the clinical community, as well as patient and consumer groups.

“UDI represents a landmark step in improving patient safety, modernizing our post-market surveillance system for medical devices, and facilitating medical device innovation,” said Jeffrey Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health.

The UDI system consists of two core items. The first is a unique number assigned by the device manufacturer to the version or model of a device, called a unique device identifier. This identifier also will include production-specific information such as the product’s lot or batch number, expiration date and manufacturing date when that information appears on the label.

The second component is a publicly searchable FDA database called the Global Unique Device Identification Database (GUDID) that will serve as a reference catalogue for every device with an identifier. No identifying patient information will be stored in this device information center, according to the agency.

The FDA plans to phase in the UDI system, focusing first on high-risk medical devices. Many low-risk devices will be exempt from some or all of the requirements in the final rule.

Once fully implemented, the UDI system rule is expected to have many benefits for patients, the health care system and the device industry. It will enhance the ability to quickly and efficiently identify marketed devices when recalled, improve the accuracy and specificity of adverse event reports and provide a foundation for a global, secure distribution chain, helping to address counterfeiting and diversion. It will also offer a clear way of documenting device use in electronic health records and clinical information systems.

“A consistent and clear way to identify medical devices will result in more reliable data on how medical devices are used. In turn, this can promote safe device use by providers and patients as well as faster, more innovative, and less costly device development,” said Shuren.

The FDA issued the proposed rule requesting input from industry, the clinical community and patient and consumer groups in July last year.

According to FDA officials, the agency tried reduce the burden on industry by building upon systems already in place. The UDI system is a key component of the National Medical Device PostMarket Surveillance System proposed in September 2012.

In general, high-risk medical devices (Class III) will be required to carry unique device identifiers on their label and packaging within one year, and this number and corresponding device information must be submitted to the new database. Manufacturers will have three years to act for most Class II (moderate risk) devices. Manufacturers of Class I devices not exempt from UDI requirements will have five years to act.

Included the announcement is the publication of a draft guidance for manufacturers outlining how to submit information to the database.

The Advanced Medical Technology Association (AdvaMed), the industry’s largest trade group, was quick to respond to the announcement.

Janet Trunzo, senior executive vice president of technology and regulatory affairs for AdvaMed said the group was still reviewing the rule’s final rule, but commended the FDA for addressing many of the issues that industry raised in the proposed rule.

“We have long supported a UDI system for medical devices that, if appropriately implemented, holds the promise of more accurate and useful post-market surveillance and more rapid medical technology improvements. And this rule is a good step toward achieving that goal,” Trunzo said. “We are pleased that FDA recognizes the difficulty and limited benefit of direct marking of implants and has eliminated this requirement. Similarly, we commend FDA for concluding that multiple single-use devices within multi-packs only need the UDI on the multi-pack and not the individual device.”

One of the industry’s concerns was that many manufacturers will have extensive inventories of product when the UDI rule goes into effect. Trunzo said she was “encouraged” that FDA understands this issue and will allow an additional three years for inventories to be depleted.

“Also, in line with industry recommendations, FDA acknowledges that one year may not be enough time to implement a UDI system for all Class III devices and will allow firms to petition to extend the implementation period based on public health and supply disruption issues,” Trunzo added. “Finally, while FDA recognizes the ISO date format is more appropriate than their proposed American format, we are puzzled that the final rule includes the day of the month for expiration dates when expiration date testing generally does not include the day of the month.”

Implementation of the UDI system will be a “costly and challenging endeavor, Trunzo said.
“It is imperative that it is implemented correctly the first time, and that its ongoing use is practical, economical, and of value to patients, healthcare providers, industry and FDA,” she said.