By Jim Dickinson
FDA says that to conform to change made under the Unique Device Identification (UDI) final rule, it has stopped issuing National Health Related Items Code (NHRIC) and National Drug Code (NDC) labeler codes to manufacturers for use with medical devices.
Previously, a notice says, manufacturers and distributors wanting to use the NHRIC system for unique product identification could apply to the agency for a labeler code.
Use of the NHRIC and NDC system for medical devices is being phased out over a time period that corresponds with the compliance dates for UDI requirements, the notice says. On the date that a medical device must have a unique identifier on its label, any NHRIC or NDC labeler codes assigned to the device are rescinded and may no longer be provided on the device label or package. For devices not required to have a UDI on their labels, any NHRIC or NDC code assigned to them are rescinded and may no longer be present on the device label or package after 9/24/18.
Labelers who want to continue to use a previously issued NHRIC or NDC labeler code until the compliance date must submit their request to FDA by September 24, 2014, and receive approval for continued use.
Jim Dickinson is MD+DI's contributing editor.