Enforcement Policy on National Health Related Item Code (NHRIC) and N​ational Drug Code (NDC) Numbers Assigned to Devices

Your chance to be heard!!FDA wants your comments

FDA announced an opportunity for public comment on the guidance document, “Enforcement Policy on National Health related Item Code and National Drug Code Numbers Assigned to Devices”. The guidance highlights FDA’s intent to stop providing NHRIC and NDC number for Medical devices manufactured and Labeled prior to September 24, 2018. The issuance of UDIs will continue till September 24, 2018.

The Final UDI rule of September 24, 2013 (78 FR 58786) created a standardized identification system which required the label and every device package of a medical device distributed in USA to bear a UDI. The use of NHRIC/NDC number instead of UDI on device is being used historically by some companies. As per the proposed guidelines, the NHRIC or NDC number assigned to a device will be revoked as of September 24, 2018 to avoid confusion and have a standardized system for Devices.

For your voice to be heard and your comments to be considered, submit either electronic or written comments on the draft guidance within 60 days of Publication in FR. Submit electronic comments to regulations.gov. Submit written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852

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