FDA announce draft guidance on UDI

Earlier this month, the Food and Drug Administration (FDA) released a draft guidance document, “Enforcement Policy on National Health Related Item Code and National Drug Code Numbers Assigned to Devices; Draft Guidance for Industry and Food and Drug Administration Staff.”

Medical devices currently available through a pharmacy and potentially eligible for reimbursement from payers are generally labelled with an 11-digit reimbursement number. This is typically a National Health Related Item Code (NHRIC) or National Drug Code (NDC) number.

The Unique Device Identification System final rule (UDI Rule) includes a provision (21 CFR 801.57) that rescinds any NHRIC or NDC number assigned to a medical device.

• If a device is required to bear a UDI on its label, any NHRIC or NDC number assigned to that device is rescinded and may no longer be on the device label or on any device package on the compliance date established by the FDA in conjunction with the UDI Rule. The compliance date for when a device is required to bear a UDI on its label can be found on the Agency’s UDI Compliance Dates webpage.
• If a device is not required to bear a UDI on its label, any NHRIC or NDC number assigned to that device is rescinded as of September 24, 2018, and may no longer be on the device label or on any device package.

When finalised, this draft guidance will describe the Agency’s intent not to enforce before September 24, 2021, the prohibition against providing NHRIC or NDC numbers on device labels and packages, with respect to class III devices, devices licensed under the Public Health Services (PHS) Act, class II devices, and implantable, life-supporting or life-sustaining devices, manufactured and labelled prior to September 24, 2018. In the draft guidance, the Agency is also proposing to extend the deadline to request use of FDA-issued labeller codes under a system for the issuance of unique device identifiers (UDIs) to September 24, 2018 (an extension from the 2014 deadline).

While implementing UDI requirements according to the scheduled UDI compliance dates is important to achieving the UDI Rule objectives in a timely manner, it is not our intent to disrupt existing reimbursement, supply chain, and procurement processes, or to potentially interfere with patients’ access to treatment. Additional time is appropriate for stakeholders to make changes to ensure that these processes will not depend on NHRIC and NDC numbers.