LOINC Mapping Manuals

The purpose of this procurement is to sponsor the development of an unambiguous step-by-step manuals defining how to map LOINC to IVD devices. Bridging this knowledge gap identified by multiple stakeholders within government, industry and laboratories will advance the CDRH priority to facilitate a standardized mechanism represent laboratory data in RWE that will align with the national strategy for improving the interoperability of electronic healthcare information. This effort is expected to also have a significant impact on FDA's ability to accelerate clearance of IVD devices through the availability of post-marketing evidence, real-time epidemiology, clinical decision support and research related to key diseases, including (but not limited to) opioid overdose, renal failure, cancer, and much more.