HIBCC Industry News
Although our scope has expanded beyond the initial HIBC labeling mandate issued 30 years ago, we have continued to emphasize ‘safety first’ through the years.
As such, the Health Industry Business Communication Council has an important advocacy and educational role in today’s healthcare industry. We are proud to act as the forum through which consensus can be reached as all parties work together to ensure a safer, more efficient industry.
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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 →
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 →
The draft guidance was issued to provide clarification on the UDI labeling requirements. To download the draft guidance on Form and Content of the UDI click here.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 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 →
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 →
To view the latest revision of the proposed Regulation on medical devices Click Here read more →
- 07 Sep 2016FDA extends UDI compliance date for Class II convenience kits and repackaged single-use devices
- 30 Aug 2016New Version of “Create a HIBC UDI & Bar Code” Utility Now Available
- 26 Jul 2016FDA releases draft guidance on UDI form and content
- 15 Jul 2016Medicare endorses unique identifiers for medical devices
- 01 Jul 2016HIN Distribution Files Available Online