FDA releases guidance to promote IVD device data interoperability and RWE efforts


On June 15th, 2018, FDA released the Guidance for Industry and FDA Staff “Logical Observation Identifiers Names and Codes for In Vitro Diagnostic Tests” IVD LOINC Guidance to encourage consistency in the coding of IVD tests by addressing questions regarding the distribution of LOINC codes by IVD test manufacturers to users. This guidance helps provide regulatory clarity around the voluntary provision of LOINC codes to end users, including codes for uncleared or unapproved indications when a clinical laboratory or other persons make an unsolicited request to manufacturers for LOINC codes. This guidance also highlights appropriate mechanisms to transmit coding, e.g., LIVD, created by the IVD Industry Connectivity Consortium (IICC). This guidance strongly supports the SHIELD initiative to improve national laboratory data infrastructure and forward the common goals of our public-private partnership to build a National Evaluation System for healthcare Technology (NEST). For more information on the LOINC guidance or to get involved in SHIELD, please contact FDA’s Digital Health team or Michael Waters, Ph.D.