FDA Enforcement Policy Regarding Use of National Health Related Item Code and National Drug Code Numbers on Device Labels and Packages
标准简介
Enforcement Policy Regarding Use of National Health Related Item Code and National Drug Code Numbers on Device Labels and Packages[附网盘链接]是Food&Drug Administration发布的FDA标准，适用于United States。标准截图
![Enforcement Policy Regarding Use of National Health Related Item Code and National Drug Code Numbers on Device Labels and Packages[附网盘链接]](/img/20210914103740g3jq5.jpg)
标准文档说明
标准文档类型为Enforcement Policy Regarding Use of National Health Related Item Code and National Drug Code Numbers on Device Labels and Packages[附网盘链接]高清PDF版本（文字版），标准文档内可进行搜索，可以复制原文，可粘贴。标准部分原文
Enforcement Policy Regarding Use of National Health Related Item Code and National Drug Code Numbers on Device Labels and Packages Guidance for Industry and
Food and Drug Administration Staff
This guidance represents the current thinking of the Food and Drug Administration (FDA or Agency) on this topic. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. To discuss an alternative approach, contact the FDA staff or Office responsible for this guidance as listed on the title page. I. Introduction
This guidance describes the Agency’s policy regarding the prohibition against providing National Health Related Item Code (NHRIC) or National Drug Code (NDC) numbers on device labels and device packages set forth at 21 CFR 801.57(a)-(b). As described below, FDA does not 1
intend to object to the use of legacy FDA identification numbers on device labels and packages for finished devices manufactured and labeled prior to September 24, 2023. In addition, this guidance addresses requests for continued use of FDA labeler codes under a system for the issuance of unique device identifiers (UDIs). FDA issued a previous version of this guidance on August 30, 2016 (“original guidance”), which stated that the Agency did not intend to enforce the regulation prohibiting 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. For reasons described below, FDA 1
For the purpose of this document, “legacy FDA identification numbers” refers to both NHRIC and NDC numbers created using labeler codes previously assigned to device manufacturers by FDA. The requirements at 21 CFR 801.57 concern only the use of legacy FDA identification numbers for devices – specifically, NHRIC and NDC numbers – 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 FDA’s unique device identification 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 and requires discontinuation of their use on a device label. (78 FR 58792).
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