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FDA Issues Draft Guidance on Coding for IVDs

June 26, 2018

The FDA called for consistent coding of in vitro diagnostic tests in a new draft guidance and urged devicemakers to use Logical Observation Identifiers Names and Codes.

The agency said LOINC coding is voluntary but it “strongly encourages the use of consensus standards for coding of IVD tests and specifically recognizes the utility of LOINC for this purpose.”

LOINC is the IVD coding system that is most widely used by clinical laboratories and electronic health records.

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