New Version of “Create a HIBC UDI & Bar Code” Utility Now Available

August 30, 2016
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Version 2.6 of the “Create a HIBC UDI & Bar Code” utility is now available. Version 2.6 enables labelers to create UDIs & bar codes in accordance with HIBC Supplier Labeling Standard (SLS) 2.6. The public comment period has closed for SLS 2.6 and it will be posted on our website shortly (pending final approval)… read more →

FDA releases draft guidance on UDI form and content

July 26, 2016
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The draft guidance was issued to provide clarification on the UDI labeling requirements. To download the draft guidance on Form and Content of the UDI click here. To learn more about HIBCC as an FDA-accredited UDI issuing agency click here. read more →

Medicare endorses unique identifiers for medical devices

July 15, 2016
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Medicare endorses the use of unique device identifiers (UDI) in billing and claims records for medical devices. The endorsement was made in an effort to improve the identification of device malfunctions and the recall process. To read the Wall Street Journal article click here. To learn more about Unique Device Identification (UDI) and HIBCC as.. read more →

HIN Distribution Files Available Online

July 1, 2016
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A new set of HIN Distribution files, as of June 30, 2016, are now available for download. To download the periodic HIN Distribution from iHIN:   Access iHIN at http://www.hibcchin.org/. Enter your username and password. Click on “Download” then “Distribution Download”. Review the HIN Data Use License Agreement and enter your Subscriber Account ID. Click next… read more →

HIBCC is designated by the European Commission as a UDI Assigning Entity.

June 23, 2016
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To view the latest revision of the proposed Regulation on medical devices Click Here read more →

The Council of the European Union announced its agreement with the European Parliament to implement UDI.

June 23, 2016
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For more information Click Here read more →

HIBCC GUDID Submission Service now available.

June 23, 2016
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The HIBCC GUDID Submission service is designed to help labelers meet the FDA’s UDI data submission requirements. As an FDA-certified Third Party Submitter, HIBCC can upload labelers’ Device Identifier (DI) records to the Global UDI Database (GUDID) to ensure that they are in UDI compliance. And our service is not limited to HIBCC-registered labelers. Our fee.. read more →

EHIBCC Labeler Update Form is now available.

June 23, 2016
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To complete the form Click Here read more →

HIBCC’s Guide to GUDID Device Identifiers is now available.

June 23, 2016
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To view the full document Click Here read more →

Auto-ID Committee Meeting Scheduled for June 16, 2016

June 10, 2016
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The next meeting of the HIBCC Auto-ID Technical Committee meeting has been scheduled for Thursday, June 16, 2016 at the Cardinal Health facility in Concord, Massachusetts.   read more →