FDA Grants UDI Extension for Soft Contact Lenses

April 3, 2017
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On March 30, 2017, the FDA released a statement granting a UDI compliance extension for labelers of soft (hydrophilic) contact lenses. To view the extension letter click here. read more →

Malware Alert for HIBCC Clients

March 30, 2017
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It has been brought to our attention that some HIBCC clients are recieving emails from a Madison Brady claiming to be a HIBCC employee. The emails are coming from madisonalbrady@gmail.com and contain a PDF attachment. This individual and email address is in no way associated with HIBCC. Do not open the PDF attachment, as it.. read more →

European Parliament Expected to Adopt Medical Device Regulation (UDI) in April

March 21, 2017
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On March 7th, 2017 the Council of the European Union approved two new medical device regulations, including a regulation similar to the US FDA’s UDI rule. The European Parliament is expected to adopt both regulations in April 2017. To view the EU press release click here. read more →

Enhancement to HIBCC???s HIN System Software

March 21, 2017
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In order to expedite the processing of licensee requests for HINs, HIBCC has implemented a process to return all completed records in a partially completed work order to licensees. This system enhancement enables licensees to receive their data faster than ever. HIBCC is also encouraging licensees to consolidate work orders by sending all HIN requests.. read more →

HIN Distribution Files Available Online

January 3, 2017
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A new set of HIN Distribution files, as of December??31, 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. The.. read more →

HIN Distribution Files Available Online

October 19, 2016
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A new set of HIN Distribution files, as of October 17, 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 →

FDA extends UDI compliance date for Class II convenience kits and repackaged single-use devices

September 7, 2016
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The FDA has extended the compliance date for UDI labeling and data submission??requirements to September 24, 2018 for the class II devices listed below. All other class II devices are subject to the September 24, 2016 UDI compliance date. Collections of two or more different devices packaged together in which the devices in the package.. read more →

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 →