The QMN Weekly Bulletin
Medical Devices / Regulatory Affairs

FDA Won’t Enforce UDI Labeling for Devices Made Before September 2021

Oct. 7, 2016
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The FDA announced it does not intend to enforce the requirement to use its unique device identifier system for labels on medical devices manufactured and labeled before Sept. 24, 2021.

In final guidance issued Aug. 30, the agency said stakeholders had expressed concern that pharmacies and other entities in the supply chain were not prepared for the transition. The deadline for labeling most Class I and Class II devices was Sept. 24.

The UDI codes are replacing the National Health Related Item Code and National Drug Code numbers used on device labels and device packages. On the date a device or device package is required to bear a UDI code on its label, the NHRIC and NDC numbers would not be allowed.

The FDA said it “recognizes that additional time is appropriate for stakeholders to adopt medical device reimbursement, supply chain, and procurement systems . . . .”

Most of the devices at issue are the types one would find at a pharmacy, either retail or hospital-based, according to Donald Guthner, principal with the consulting firm Orgenix. The rule covers a broad array of items, he said.

Guthner said the UDI requirements will impose substantial burdens on smaller companies, which lack the administrative capabilities of larger companies to manage what is essentially a new inventory control system. He added that while the NHRIC and NDC numbers are permanent and could be easily stored in a computer for reimbursement purposes, the UDI numbers will change with every batch. This will make it difficult for small companies to keep up.

Although the enforcement reprieve is welcome, it is only “postponing the inevitable,” Guthner said. “It’ll cost a lot, especially when they start enforcing it.”

Push for UDI on Insurance Forms

Meanwhile, Sen. Charles Grassley (R-Iowa) and Elizabeth Warren (D-Mass.) are ramping up pressure on the Accredited Standards Committee X12 (ASC X12) to include UDIs on health insurance claim forms. ASC X12 is the body responsible for setting standards for and recommending changes to the standard electronic claims forms.

“Collecting device identifiers on insurance claims forms would allow device performance and safety concerns to be tracked and evaluated at the model level, enable the collection and analysis of detailed device and patient data, facilitate outcome comparisons across device models, and protect the integrity of the Medicare program by allowing for faster identification of poorly performing and recalled devices and ensuring that proper reimbursements take place with regard to these devices,” the senators wrote in an Aug. 29 letter.

The senators asked the standards committee to brief their staffs on the actions it is taking to finalize the next version of standards associated with electronic claims forms and its discussions related to incorporating UDIs.

In March, the two lawmakers pushed the Centers for Medicare & Medicaid Services to work with the FDA to incorporate UDIs into insurance claims forms.

As a result, Medicare said it would recommend that UDIs be included in medical billing records.

In July, CMS Acting Administrator Andrew Slavitt and FDA Commissioner Robert Califf sent a letter to the ASC X12, urging it to revisit its requirements to support capturing UDI on claim forms for high-risk devices.

The final rule establishing the UDI system was published in 2013, and is being phased in over seven years based on device classification. The FDA issued draft guidance in July that clarified agency expectations for UDIs, which must appear in two forms on device labels and packages: an easily readable plain-text form and an automatic identification and data capture technology form.

A recent industry survey indicated that only about 15 percent of device manufacturers of Class II and Class III devices are currently compliant with new unique device identifier requirements that are scheduled to go into effect Sept. 24. Roughly half of the 120 medical device companies polled hadn’t even conducted internal audits, and 53 percent said they would need additional support for their UDI processes to meet the regulatory requirements.

The next time you hear about UDIs, it may be from an FDA investigator. Will you be ready with an answer? Implementing UDI is a huge challenge. That's why FDAnews developed the new management report Unique Device Identifier (UDI) Rule Implementation and Compliance Guide.

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