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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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The draft guidance was issued to provide clarification on the UDI labeling requirements. To download the draft guidance on Form and Content of the UDI click here.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 →
The Council of the European Union announced its agreement with the European Parliament to implement UDI.
For more information Click Here read more →
- 12 Sep 2017HIN Distribution Files Available Online
- 03 Jul 2017HIN Distribution Files Available Online
- 05 Jun 2017FDA Extends UDI Compliance Deadline for Class 1 Devices
- 26 May 2017FDA Posts New Webpage on Use of Symbols in Labeling
- 07 Apr 2017European Parliament Votes to Adopt Medical Device Regulation Proposal