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Lorem ipsum dolor sit amet, consectetur adipiscing elit. Proin sed diam sapien. Sed semper urna dictum tellus lacinia vehicula. Ut volutpat, augue vel auctor tincidunt, ligula sem pharetra dui, nec tincidunt ante mauris eu diam. Phasellus viverra nisl vitae cursus euismod. Suspendisse sit amet est lectus.
Lorem ipsum dolor sit amet, consectetur adipiscing elit. Proin sed diam sapien. Sed semper urna dictum tellus lacinia vehicula. Ut volutpat, augue vel auctor tincidunt, ligula sem pharetra dui, nec tincidunt ante mauris eu diam. Phasellus viverra nisl vitae cursus euismod. Suspendisse sit amet est lectus.
Lorem ipsum dolor sit amet, consectetur adipiscing elit. Proin sed diam sapien. Sed semper urna dictum tellus lacinia vehicula. Ut volutpat, augue vel auctor tincidunt, ligula sem pharetra dui, nec tincidunt ante mauris eu diam. Phasellus viverra nisl vitae cursus euismod. Suspendisse sit amet est lectus.
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.
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.