FDA Final Guidance on Logical Observation Identifiers Names and Codes (LOINC) for In Vitro Diagnostic Test

FDA Final Guidance on Logical Observation Identifiers Names and Codes (LOINC) for In Vitro Diagnostic Test

Today, the FDA published the “Logical Observation Identifiers Names and Codes for In Vitro Diagnostic Test” final guidance. This guidance addresses regulatory-specific questions about the distribution of Logical Observation Identifiers Names and Codes (LOINC) codes by in vitro diagnostic (IVD) test manufacturers to users, primarily clinical labs and electronic health record (EHR) software vendors. This guidance focuses exclusively on the appropriate use of LOINC codes for specific types of IVD tests and does not address coding of test results for interoperability or unique device identification. LOINC codes describe the types of IVD tests in electronic data information systems by providing a unique numeric code, accompanied by names that specify attributes of the IVD test such as analyte measured, sample type, and kind of property/quantity. The FDA recognizes that with the increasing implementation of EHRs, there is a need to standardize the way IVD tests are coded. Standardizing information captured and stored in EHRs could expedite access to patient diagnostic information for health care providers, reduce burdens to labs for connecting new diagnostic systems to Laboratory Information Systems, and facilitate the use of health care information for decision support tools and real-time tracking of infectious disease outbreaks. If you have any questions regarding this guidance document, please contact CDRH’s Division of Industry and Consumer Education (DICE) at DICE@fda.hhs.gov, 1-800-638-2041, or 301-796-7100. Food and Drug Administration Center for Devices and Radiological Health