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
- Docket Number:
- Issued by:
Guidance Issuing OfficeCenter for Devices and Radiological HealthCenter 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).
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:
Food and Drug Administration
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Rockville, MD 20852
All written comments should be identified with this document's docket number: FDA-2016-D-0199.