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FDA Pushes Back Enforcement of UDI Rule Provisions

Posted 29 August 2016 | By Zachary Brennan 

FDA Pushes Back Enforcement of UDI Rule Provisions

The US Food and Drug Administration (FDA) on Monday finalized guidance that makes clear the agency will not enforce a deadline for certain unique device identifier (UDI) provisions after commenters on the draft guidance said they would not be able to meet the deadline in time.

The shift in enforcement comes as FDA says it wants to make sure it gives companies enough time to make changes to the medical device reimbursement, supply chain and procurement systems and processes so that they will not depend on National Health Related Item Code (NHRIC) or National Drug Code (NDC) numbers.

The change of heart follows FDA's draft guidance detailing how it would enforce a prohibition on NHRIC or NDC numbers for device labels and packaging for certain devices beginning 24 September 2018.

But on Monday, FDA said that after stakeholders, including supply chain participants, pharmacies and payers, said they would not be able to complete the work to transition away from the use of NHRIC and NDC numbers by 24 September 2018, and FDA “does not intend to enforce this prohibition with respect to finished devices that are manufactured and labeled prior to September 24, 2021. In addition, this guidance describes the Agency’s intent to consider requests for continued use of FDA labeler codes under a system for the issuance of unique device identifiers (UDIs) that are submitted before September 24, 2021.

“We expect the UDI labeling requirements will be fully implemented by September 24, 2021,” FDA said Monday in the Federal Register. “We also believe additional time is appropriate for stakeholders to adopt medical device reimbursement, supply chain, and procurement systems, which do not depend on having an NHRIC or NDC number on the device label.”

The agency added that it recognizes that the effect of this policy may be to extend the time that there will be multiple identifiers on device labels, which could potentially be confusing, though “the risk of confusion is outweighed by the threat of disrupting reimbursement, supply chain, and procurement processes and potentially interfering with patient access to devices.”

Comments

FDA said it received 13 sets of comments on the draft guidance, the majority of which said they would not be able to complete the work to transition away from use of NHRIC and NDC numbers by September 24, 2018.

“Some commenters also expressed concern that after September 24, 2021, retailers and pharmacies would need to send some devices with shelf lives exceeding 3 years, and with NHRIC or NDC numbers on their labels or device packages, back to the device labelers,” the agency says. “FDA has revised the guidance to reflect the Agency’s intent not to enforce the prohibition against providing NHRIC and NDC numbers on device labels and device packages, with respect to finished devices that are manufactured and labeled prior to September 24, 2021.”

Background

Historically, companies have placed NHRIC or NDC numbers on the labels and packages of certain medical devices. Devices available through a pharmacy and potentially eligible for reimbursement from payers are generally labeled with an 11-digit reimbursement number, typically using an NHRIC or NDC number assigned to the device.

But to further the objectives of creating a national device identification system, the UDI Rule, established in the Food and Drug Administration Amendments Act of 2007 (FDAAA), includes a provision that rescinds any NHRIC or NDC number assigned to a device.

“As explained in the proposed rule to establish a unique identification system, continued use of NHRIC and NDC numbers on device labels and device packages could cause confusion regarding appropriate identification of the device or obscure the distinction between drug and device identification systems,” FDA says.

During the phased implementation of the UDI requirements, some device labels will bear UDIs and others will bear different types of identifiers, the agency notes.

“Our intent is that this enforcement policy will both facilitate a consistent date by which all classes of devices have legacy NHRIC and NDC numbers removed, and make the transition away from using these legacy FDA identification numbers less disruptive and more predictable,” according to the guidance.

But the agency says that it recognizes that additional time is appropriate for stakeholders to make changes to ensure that device reimbursement, supply chain and procurement systems and processes will not depend on NHRIC and NDC numbers.

UDI

Enforcement Policy on National Health Related Item Code and National Drug Code Numbers Assigned to Devices Guidance for Industry and Food and Drug Administration Staff


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