NEW YORK (360Dx) – The US Food and Drug Administration will not require makers of in vitro diagnostic devices to include laboratory coding numbers with their products.
In a guidance document issued late last week, the FDA said that it "strongly encourages the use of consensus standards for coding of IVD tests," but insisted that the process should remain voluntary. Specifically, the agency named the Logical Observation Identifiers Names and Codes (LOINC) system as an effective tool for test coding.
LOINC, a standard developed by the Regenstrief Institute, helps map lab results into electronic health records. The FDA said in its guidance that it supports efforts to promote semantic interoperability between medical devices and EHRs as a means of reducing risks to patients.
"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," the document said.
Any LOINC codes that device makers offer to customers in official documentation must be associated with FDA-approved and FDA-cleared indications, and manufacturers must avoid off-label linkages unless individual labs or users specifically request this information, according to the regulatory agency.
"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," the guidance said.
The FDA did not mention LIVD, a year-old standard that seeks to link IVD tests with LOINC codes.