October 21 2022
FDA has announced the availability of final guidance entitled “Enforcement Policy Regarding Use of National Health Related Item Code and National Drug Code Numbers on Device Labels and Packages.”
This guidance provides information about the use of of National Drug Code (NDC) and National Health Related Item Code (NHRIC) created using labeler codes previously assigned to device manufacturers by the FDA (referred to here as “legacy FDA identification numbers”) on device labels and the enforcement policy related to these legacy identifiers.
It includes responses to common questions about the guidance to help device labelers preparing to transition into compliance. The FDA expects device manufacturers and/or labelers to be aware of UDI and other FDA regulatory requirements.
For finished devices manufactured and labeled prior to September 24, 2023, the guidance states that the FDA does not intend to object to the use of legacy FDA identification numbers on device labels and device packages.
For devices manufactured and labeled on or after September 24, 2023, this policy does not apply.
: Frequently Asked Questions
Q1: Why are there legacy FDA identification numbers currently on devices?
A: Before the establishment of the FDA’s Unique Device Identification system (UDI System) and the publication of the UDI Rule in 2013, the absence of a standardized, unique identification system for devices led companies to use various identifiers for inventory, ordering, reimbursement and other purposes. In some cases, companies obtained a labeler code from the FDA, which they used to create “NHRIC” or “NDC” numbers that they placed on the labels and packages of certain medical devices.
It is the FDA’s understanding that reimbursement and other systems in certain settings, such as retail pharmacies, have relied on use of these legacy identifiers and have not been updated to utilize unique device identifiers (UDIs), which have a different format and often more characters than a legacy FDA identification number.
Q2: How were legacy identifiers generated?
A: Some device manufacturers had labeler codes previously assigned to them by the FDA, which they used to generate numbers that were labeled as “NHRIC” or “NDC” on device labels or packages. The FDA does not assign new labeler codes for the purposes of generating NDCs for non-drug products or for use under a system for the issuance of UDIs.
Q3: How did the UDI Rule affect the use of legacy FDA identification numbers?
A: The UDI Rule includes a provision that rescinds any NHRIC or NDC assigned to a medical device. On the date a medical device must bear a UDI on its label, any NHRIC or NDC assigned to the device is rescinded and may no longer be on the device label or on any device package (21 CFR 801.57(a)). 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 (21 CFR 801.57(b)).
We note that, although 21 CFR 801.57 rescinds any NHRIC or NDC number “assigned” to a device, such NDCs are not assigned in compliance with 21 CFR 207.33. Instead, some device manufacturers had labeler codes previously assigned to them by the FDA, which were used to create numbers that were labeled as “NHRIC” or “NDC.” Under 21 CFR 207.37(a)(3), products such as medical devices may be deemed misbranded if they use an NDC. However, the FDA does not intend to object to the use of legacy NDCs on device labels and device packages manufactured and labeled prior to September 24, 2023 as described in the May 2021 guidance.
Q4: What guidance has the FDA issued on implementation of the UDI Rule requirements for legacy FDA identification numbers?
A: Following the publication of the UDI Rule, the FDA received feedback from stakeholders that removing legacy FDA identification numbers from device labels and packages according to the timeframe specified in 21 CFR 801.57 could disrupt pharmacy reimbursement, supply chain, and procurement processes. In 2016, after considering this feedback, the FDA issued guidance to communicate the enforcement policy that we did not intend to object to the use of legacy FDA identification numbers, that is, legacy NHRIC or NDC numbers, on device labels and packages for finished devices manufactured and labeled prior to September 24, 2021.
In May 2021, in recognition of the challenges the COVID-19 public health emergency presented to the entire health care system and other considerations, including the need for many stakeholders to shift priorities as part of the COVID-19 response effort, the FDA extended this policy for two additional years. The FDA explained that extending the policy for a limited additional time as stakeholders worked to transition away from the use of legacy NHRIC and NDC numbers on device labels and in various systems was appropriate and in the interest of the public health.
Q5: To what devices does the enforcement policy apply?
A: As indicated in the May 2021 guidance, the FDA extended this policy for a limited additional time as stakeholders worked to transition away from use of legacy NHRIC and NDC numbers on device labels and packages and in various systems.
For finished devices that are manufactured and labeled prior to September 24, 2023, the guidance explains that the FDA does not intend to object to the use of legacy FDA identification numbers on device labels and device packages;
For finished devices that are manufactured and/or labeled on or after September 24, 2023, this policy does not apply.
As device manufacturers and/or labelers prepare to transition into compliance, the FDA expects them to be aware of UDI and other FDA regulatory requirements.
Q6: Does the UDI Rule prohibit use of numbers or identifiers other than UDIs for things like ordering, reimbursement, or other activities?
A: The requirements at 21 CFR 801.57 concern only the use of legacy FDA identification numbers for devices and do not prohibit the inclusion on device labels and packages of other numbers used to facilitate ordering, reimbursement, inventory stocking, or other supply chain activities. As explained in the preamble to the final rule establishing the FDA’s UDI System:
“The use of catalog numbers, inventory numbers, ordering numbers, or any other identification number is neither prohibited nor regulated by this rule, except that § 801.57 rescinds certain legacy FDA identification numbers [(i.e., NHRIC and NDC numbers)] and requires discontinuation of their use on a device label.” (78 FR 58792).
Q7: Does the enforcement policy regarding FDA legacy identification numbers affect whether or when devices must use a UDI for identification purposes?
A: No. The enforcement policy described in the May 2021 guidance applies to the requirement that labelers no longer use an NHRIC or NDC number on a device label or device package as of the dates specified under 21 CFR 801.57(a)-(b); it does not extend to any of the other requirements under the UDI Rule.
Although this enforcement policy does not affect whether devices (including devices that have had an NDC or NHRIC number on their labels) must bear a UDI on their label for identification purposes, we note that most devices will be required to bear a UDI by September 24, 2023.
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SOURCE :
https://www.fda.gov/medical-devices/unique-device-identification-system-udi-system/legacy-identification-number-ndcnhric-frequently-asked-questions