FDA encourages the adoption of the IVD Industry Connectivity Consortium’s LIVD format for distribution of LOINC codes for IVD tests

2019/03/26

The US Food and Drug Administration published a Guidance for Industry and Food and Drug Administration Staff, titled ”Logical Observation Identifiers Names and Codes for In Vitro Diagnostic Tests” in which it encourages the adoption of the IVD Industry Connectivity Consortium’s LIVD format for distribution of LOINC codes for IVD tests. The FDA recognizes LIVD as a consensus standard that contributes to greater semantic interoperability within and across laboratories.

LIVD (Digital Format for Publication of LOINC to Vendor IVD Test Results) defines the digital publication of LOINC using vendor defined IVD tests associated with a set of predefined LOINC codes. LIVD assures that laboratory personnel select the appropriate LOINC codes for IVD test used by their laboratory. It also allows LIS systems to automatically map the correct IVD vendor test result to a LOINC code.

For more information on LIVD go to http://ivdconnectivity.org/livd/

For a copy of the June 15, 2018 FDA Guidance for Industry and Food and Drug Administration Staff, titled ”Logical Observation Identifiers Names and Codes for In Vitro Diagnostic Tests” go to https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM610636.pdf

The IVD Industry Connectivity Consortium (IICC) is a global, nonprofit organization dedicated to creating and encouraging adoption of a unified connectivity standard to reduce the cost and variability of data exchange between IVD devices and healthcare informatics in clinical laboratories. This will improve healthcare efficiency and patient care. For more information contact:

Serge Jonnaert, President
IVD Industry Connectivity Consortium
+1(949)259-3807
serge.jonnaert@ivdconnectivity.org