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FDA Issues Frequently Asked Questions (FAQs) on End of UDI Enforcement Policy and Alternatives

The U.S. Food and Drug Administration (FDA) is reminding device industry and unique device identification (UDI) program stakeholders that the enforcement policy described in the May 2021 guidance document, Enforcement Policy Regarding Use of National Health Related Item Code and National Drug Code Numbers on Device Labels and Packages is applicable to devices labeled prior to September 24, 2023. Devices labeled on or after September 24, 2023, must comply with all applicable UDI requirements, including the prohibition on the use of certain legacy FDA identification numbers (National Drug Code (NDC) and National Health Related Item Code (NHRIC) numbers) on the label. To help stakeholders prepare, the Agency is posting frequently asked questions (FAQs) to the FDA website.

In addition, the FDA is posting FAQs on universal product code (UPC) alternatives UDI-A160001 and UDI-A160002. These time-limited alternatives will also end on September 24, 2023.

Questions?

If you have questions about the use of NHRIC and NDC numbers on device labels and packages, contact the unique device identification (UDI) system help desk.