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GUIDANCE DOCUMENT

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 May 2021

Download the Final Guidance Document Read the Federal Register Notice
Final
Docket Number:
FDA-2016-D-0199
Issued by:
Guidance Issuing Office
Center for Devices and Radiological Health
Center for Biologics Evaluation and Research

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 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).

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You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2016-D-0199.

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