FDA supports the voluntary inclusion of LOINC codes for IVD tests in labeling if the information is accurate and consistent with the approved or cleared indications for the device. FDA does not intend to perform premarket review of LOINC codes that manufacturers may choose to provide to clinical laboratories or to other users. However, device labeling remains generally subject to other requirements of the Federal Food, Drug, and Cosmetic Act, including misbranding and adulteration.
Manufacturers may choose to include LOINC codes in printed labeling or to include a reference to a location external to the labeling that lists or otherwise provides LOINC codes for the IVD test. For example, labeling could include a hyperlink to a web site with a table of LOINC codes associated with the manufacturer’s test(s). LOINC codes incorporated directly into devices – for example, LOINC codes included with device output that is directly transferred to an external system such as an LIS – may be subject to quality system requirements applicable to the device.
