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.
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.
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.
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 […]
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.
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 […]
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 […]
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. […]
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 […]
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). […]
