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GUIDANCE DOCUMENT

Enforcement Policy on National Health Related Item Code and National Drug Code Numbers Assigned to Devices Guidance for Industry and Food and Drug Administration Staff August 2016

Final
Docket Number:
FDA-2016-D-0199
Issued by:
Guidance Issuing Office
Center 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.


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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.