FDA Issues Final UDI Guidance Document

Eight years after issuing the unique device identifier (UDI) rule and five years after releasing the draft guidance, on July 7, 2021, the FDA published the final guidance in the Federal Register.

“Reduce Medical Errors”

Back in 2013, the FDA said the rule "will substantially reduce existing obstacles to the adequate identification of medical devices used in the United States." It will reduce medical errors resulting from misidentification of a device or confusion on how to use it.

The UDI rule requires that every medical device bear a UDI on the label and package of the device. The devices are required to bear a permanent marking with the UDI on the device itself, or, if the device is intended to be used more than once and reprocessed before each use. The rule also includes special labeling requirements for stand-alone software regulated as a device.

Forms of UDI

According to final FDA guidance, the UDI must be presented in two forms on the device label and device packages:

1. easily readable plain-text; and
2. automatic identification and data capture (AIDC) technology.

The UDI can be provided through either or both easily readable plain-text and AIDC technology forms, or through any alternative technology that will provide the UDI of the device on demand.

The guidance, aimed at labelers and FDA-accredited issuance agencies, “describes the requirements for and the FDA's recommendations regarding the form and content of the UDI to help ensure that the UDIs developed under systems for the issuance of UDIs meet the objectives of the Unique Device Identification System Final Rule, 78 FR 58786."

It describes the two forms of a UDI, clarifies the content of the UDI, and addresses the use of data delimiters that identify specific data elements within the UDI. The guidance also addresses the recommended order of the data in the text form of a UDI carrier.

The guidance does not apply to universal product codes.

Industry Concerns

After the draft guidance was issued five years ago, the agency took public comments into consideration before issuing this final version.

It was not without disagreement from the medical device industry.

Regulatory Focus reported that the agency "rebuffed industry’s requests for several changes to the document, including as they relate to data delimiters and FDA’s recommendations on the order of data represented in the plain-text form."

Specifically, AdvaMed didn't like the rule on data delimiters. “FDA’s rules specifically define a UDI to be composed of a device identifier (“DI”) and product identifier (“PI”) … Data delimiters are not mentioned in the Agency’s rules, nor are they even contemplated in the Preamble to the Federal Register Notice announcing the rule,” AdvaMed wrote.

The agency said data delimiters are an important key to UDI comprehensibility and utility.

"A data delimiter indicates and distinguishes each data element within the data string represented in the UDI carrier, and inclusion of data delimiters is important for both the easily readable plain-text and AIDC forms of the UDI."

AdvaMed had also called for the agency to remove a section for how the elements UDI carrier should be ordered. The industry group pointing out that the UDI Final Rule “does not prescribe an order for UDI and non-UDI elements in the UDI carrier.”

Thanks, but no thanks, said the FDA and opted to keep its recommendations on the order of the data represented in the UDI carrier largely unchanged.

Informing the Future

If the UDI requirements work out as policymakers and regulators hope, it will not only make devices safer, but bring about a whole new set of data points for payers, providers, and engineers for the next generation of devices.

Here is a link to the FDA site on UDIs.