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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A new set of HIN Distribution files, as of June 30, 2017, 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 →
The FDA has extended the UDI compliance deadline for Class 1 and Unclassified devices to September 24, 2020 for both labeling and GUDID submissions. To view the official FDA letter click here. read more →
The FDA Final Rule on Use of Symbols in Labeling allows the use of symbols without explanatory text. To learn more click here to be taken to the Use of Symbols in Labeling webpage. read more →
On April 5, 2017 the European Parliament adopted two new regulations on medical and in-vitro diagnostic devices. The new EU rules focus on enhancement of patient safety and the modernization of the overall public health system. To read the official European Commission press release click here. read more →
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 →
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 email@example.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 →
- 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