FDA clarifies its proposed mandate, but still has 35 questions for stakeholders.

FDA has issued its proposed rule that would require most medical devices distributed in the United States to bear a unique device identifier (UDI). FDA believes that its proposal would “reduce medical errors,” enable “more rapid, more efficient” recalls, and “lead to more accurate reporting of adverse events.” The rule, published on July 10 in the Federal Register, also proposes an open database and standardized date formats for medical device labels. FDA is seeking comment on the proposal by November 7.

At GS1 Connect 2012 in June, before the draft rule was published, Jay Crowley, senior advisor for FDA’s Center for Devices and Radiological Health, explained that the agency is “trying to bring visibility and clarity to the medical device lifecycle.”

For instance, with UDI, the healthcare system “could do a lot of things much better, such as recalls, managing adverse events, and recording device use to electronic health records,” Crowley told the audience. “With adverse events, for instance, we spend too much time trying to figure out what device has been used. And most firms cannot find all their recalled items. A recent GAO study showed that manufacturers were unable to remove and/or correct 53% of Class I recalls.”

Better information could bring other benefits, too. “Because UDI allows you to document the device in the EHR, comparative effectiveness [studies] can be enabled by longitudinal views,” explained Crowley. He added that UDI could potentially play roles in FDA’s Sentinel Initiative and in postmarket surveillance.

And industry could benefit from “much better internal visibility and improved logistics,” he said.

FDA’s draft explains that a UDI may consist of two parts:

• A device identifier that identifies the specific version or model of a device and the labeler of that device; and
• A production identifier that identifies one or more of the following, when present on the label of the device:

- The lot or batch within which a device was manufactured.
- The serial number of a specific device.
- The expiration date of a specific device.
- The date a specific device was manufactured.

“The production identifier must be present whenever a lot or batch number, serial number, date of manufacture, or expiration date appears on the label of the device, except for class I devices,” the agency explains in the draft. “This proposed rule would not itself require any production identifier to appear on a device label, but other FDA regulations and conditions of approval may require one or more to be provided on the label of a particular device or type of device, and many labelers already label their devices with one or more production identifiers.”

Crowley explained at GS1 Connect that “not all devices require production identifiers. The granularity of marking is based on the risk of device.”

According to the proposal, each UDI would need to be provided in a plain-text version and in a form that uses automatic identification and data capture (AIDC) technology. It can be numeric or alphanumeric. Crowley said that the UDI will need to appear on all packaging levels, down to the lowest level, especially the patient-use or unit-of-use package.

For certain device categories, the UDI would also need to be marked directly on the device, such as those that remain in use for extended periods of time and are likely to become separated from their labeling.

UDI labeling requirements would also apply to the following products:

• Certain combination products.
• In most instances, to the device constituent parts of combination products.
• Convenience kits.
• A device included in a convenience kit, except for a single use device.

For example, in addition to the UDI required for the combination product, each device constituent part of that combination product is expected to have its own UDI, unless that device constituent part “is physically, chemically, or otherwise combined with other constituents of the combination product in such a way that it is not possible for the device constituent part to be used except as part of the use of the combination product,” reads the draft.

And each convenience kit is expected to have its own UDI along with the individual UDIs required for each device contained in the kit.

FDA also states that each model or version of a device would require a new UDI, as would a quantity change in a device package.

FDA does not specify or prohibit the type of AIDC technology to be used, naming bar codes, RFID, or other near-field communication as options. “We believe it is best to leave decisions concerning the selection and use of any particular AIDC technology to issuing agencies, the labeler, and the health care community in order to avoid unintentional interference with the development and adoption of new and improved AIDC technology,” FDA writes in the proposal.

FDA does not suggest a particular font or point size for the UDI, stating that the UDI “would be subject to existing requirements that govern medical device labels, including Sec. 801.15.”

FDA’s proposes accrediting multiple UDI-issuing agencies. Under certain circumstances FDA could also act as an issuing agency. These agencies would be expected to follow ISO/IEC 15459, Information Technology--Unique identifiers, and they would apply to the Registration Authority and obtain an Issuing Agency Code (IAC). “This assures that multiple issuing agencies can create globally unique identifiers and minimizes the risk of duplicative identifiers,” FDA writes. It would also help avoid the “inefficiency that would result if every labeler generated their own non-standardized identifiers or if FDA alone issued identifiers.” These agencies would be expected to maintain “a list of labelers that use its system for the assignment of UDIs and [provide] FDA with a copy of the list each year.”

FDA proposes that all UDI data be submitted to and housed in a publicly accessible Global Unique Device Identification Database (GUDID). The FDA-administered GUDID database would serve as the single authoritative repository for UDI information. “Any device that would have to be labeled with a UDI under proposed Sec. 801.20 would be subject to GUDID data submission requirements,” FDA writes. “Open access to the GUDID would also encourage the integration of UDI data into healthcare delivery support systems, electronic medical records, and procurement, inventory management, and accounting systems, and would allow those systems to work together more effectively and efficiently.”

FDA is about to begin User Acceptance Testing of the beta GUDID. GS1 is a partner in this pilot program, using the GS1 Global Data Synchronization Network (GDSN), a single, synchronized data source for product information. Testing will determine whether GDSN data can be used to submit data to the GUDID. According to Dan Wilkinson, senior vice president of marketing and commercial operations for 1SYNC—a certified GDSN data pool and wholly owned subsidiary of GS1US—the product attributes the healthcare industry is requiring for UDI will be available in GDSN. “The GDSN is being aligned with the UDI proposal requirements. We’re confident the pilot will demonstrate GDSN’s readiness to support our healthcare community’s product data requirements.”

Crowley answered several audience questions after he spoke at GS1 Connect. He clarified that device reprocessors or repackagers would be expected to add a new UDI to their products because by FDA’s definition they are manufacturers. He added that FDA will be phasing out NDC and NHRIC numbers for medical devices and replace them with the UDI, but will not be replacing NDCs for drugs with the UDI. When asked whether FDA will expect UDIs at levels lower than the sellable unit, such as for blood glucose monitoring strips, he admitted that FDA had not yet made a determination.

UDI requirements would be phased in based on device class over seven years following publication of a final rule.
Within the draft, FDA is also proposing that dates printed on medical device labels follow one specific format: “Month Day, Year, with the month shown as a three-letter abbreviation of the month (e.g. SEP 30, 2012).” Dates may be printed in any size and font.

FDA is proposing that this revision take effect one year after the final rule is published.

GS1 US and GS1 Healthcare US applauded FDA for publishing the draft regulation. “A UDI system leveraged by all constituents in the U.S. supply chain will improve the speed and accuracy of product recalls as well as adverse event reporting,” said Siobhan O’Bara, vice president for healthcare, GS1 US. “Organizations representing all aspects of the supply chain have been working together for many years to support UDI capabilities, and we are thrilled that the much-anticipated UDI draft regulation is now published. The industry is ready, willing and able to implement UDI to the benefit of patients, healthcare providers and manufacturers here in the U.S. and around the world.”

Robert Hankin of HIBCC says that HIBCC’s initial reaction is “that the ruling is consistent with our expectations, based upon various prior conferences and briefings, and that the inclusion of our widely-adopted HIBCC standards will facilitate implementation of this vital regulation.”

Ken Koldan, serving on AIM (Automatic Identification and Mobility) North America Board of Directors and as AIM North America UDI Chairman (as well as new business development executive FLEXcon Inc.), said that “AIM’s UDI Committee looks to provide comments on the technology of automatic identification and data capture (AIDC) required implementing the proposed rule. The UDI Committee is uniquely positioned to lead the appropriate technology discussion in both RFID and Data Matrix to complement GS1 Healthcare or Health Industry Bar Code (HIBC) discussions. The AIM NA UDI Committee has the mission to provide a single place for implementers of UDI to get the answers they need on AIDC technology.”

FDA has posed 35 questions on UDI to stakeholders and encourages electronic or written comments on the proposed rule by November 7.

For more details, please visit FDA's Web page dedicated to Unique Device Identification.

This article was originally published on July 3, 2012, and was updated on August 13, 2012.