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
- Collection:
- Health Policy and Services Research
- Series Title(s):
- Guidance for industry
- Contributor(s):
- United States. Department of Health and Human Services, issuing body. United States. Food and Drug Administration, issuing body. Center for Devices and Radiological Health (U.S.), issuing body. Center for Biologics Evaluation and Research (U.S.), issuing body.
- Publication:
- Silver Spring, MD : Center for Devices and Radiological Health, May 21, 2021
- Language(s):
- English
- Format:
- Text
- Subject(s):
- Government Regulation Medical Device Legislation Product Labeling United States United States. Department of Health and Human Services United States. Food and Drug Administration
- Genre(s):
- Technical Report
- Abstract:
- 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 numbers1 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 believes it is appropriate and consistent with the public health to extend this policy for an additional two years. Therefore, we do not intend to object to the use of legacy NHRIC or NDC numbers on a device label or package for finished devices manufactured and labeled prior to September 24, 2023.
- Copyright:
- The National Library of Medicine believes this item to be in the public domain. (More information)
- Extent:
- 1 online resource (1 PDF file (5 pages)).
- NLM Unique ID:
- 9918350987006676 (See catalog record)
- Permanent Link:
- http://resource.nlm.nih.gov/9918350987006676