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The draft guidance was issued to provide clarification on the UDI labeling requirements. To download the draft guidance on Form and Content of the UDI click here.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 →
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 →
- 08 Apr 2019HIBCC Releases UDI Suite
- 03 Apr 2019The Global Medical Device Nomenclature (GMDN) Membership is now available for free as of April 1st
- 26 Mar 2019Need to Make a Change to a Published UDI Record in the FDA’s GUDID?
- 19 Feb 2019Medical Technology Association of Australia (MTAA) releases final UDI System Proposal
- 05 Feb 2019MedTech Europe releases document on the differences in UDI requirements for the US and EU