Enforcement Policy on National Health Related Item Code and National Drug Code Numbers Assigned to Devices
- Docket Number:
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Guidance Issuing OfficeCenter for Devices and Radiological Health
This guidance describes the Agency’s intent regarding enforcement of 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 enforce this prohibition with respect to finished devices that are manufactured and labeled prior to September 24, 2021. In addition, this guidance describes the Agency’s intent to consider requests for continued use of FDA labeler codes under a system for the issuance of unique device identifiers (UDIs) that are submitted before September 24, 2021. For the purpose of this document, “legacy FDA identification numbers” refers to both NHRIC and NDC numbers assigned to devices.
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:
Division of Dockets Management (HFA- 305)
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.