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Regulatory Focus™ > News Articles > 6 > FDA Answers Questions on Coding of IVDs

FDA Answers Questions on Coding of IVDs

Posted 15 June 2018 | By Ana Mulero 

FDA Answers Questions on Coding of IVDs

In an effort to standardize the information gathered via in vitro diagnostic (IVD) tests, the US Food and Drug Administration issued guidance Friday providing clarifications on the distribution of codes used by manufacturers.
As adoption of electronic health record (EHR) systems continues to grow across the US, the agency argues “there has been a greater demand” for standardization of how IVDs are coded as the information from these tests “form a significant proportion of all EHRs.”
The guidance features a Q&A to address the appropriate use of Logical Observation Identifiers Names and Codes (LOINC). This coding system is currently the “most widely used by clinical laboratories and EHRs,” the agency added.
A total of four answers are described in the 8-page guidance. On whether manufacturers should include LOINC codes in device labeling, FDA says it “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.”
Other questions relate to whether FDA requires LOINC coding for IVDs, providing these codes for uncleared or unapproved use indications and formatting for distribution.
Logical Observation Identifiers Names and Codes for In Vitro Diagnostic Tests

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