Medical Devices

More about National Health Related Items Code - NHRIC

In order to conform to changes made under the Unique Device Identification (UDI) final rule, the FDA has stopped issuing National Health Related Items Code (NHRIC) and National Drug Code (NDC) labeler codes to manufacturers for use with medical devices.  Prior to the UDI final rule, device manufacturers and distributors who desired to use the NHRIC system for unique product identification could apply to the FDA for a labeler code, which is the first segment in the two-segment NHRIC number.

The use of NHRIC and NDC numbers for devices is being phased out over a time period that corresponds with the compliance dates for UDI requirements. On the date a medical device must bear a unique device identifier on its label, any NHRIC or NDC numbers assigned to the device are rescinded and may no longer be provided on the device label or package. If a device that is not required to have a UDI on its label, any NHRIC or NDC number assigned to it is rescinded and may no longer be on the device label or package after September 24, 2018. 

However, if a labeler wishes to continue to use a previously issued NHRIC or NDC labeler code within a UDI system, the labeler must submit a request to the FDA by September 24, 2014 and receive approval for continued use. For instructions on how to request continued use of an NHRIC or NDC number, please submit a question to the UDI Help Desk.

Page Last Updated: 11/03/2014
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