In general, LOINC codes provided by the manufacturer should be consistent with FDA-cleared or FDA-approved Indications for Use for that IVD test. A manufacturer’s dissemination, through, for example, inclusion in printed labeling or on manufacturer website, of a LOINC code that suggests an unapproved or uncleared indication for use may be considered evidence of a new intended use and result in the device being considered adulterated and/or misbranded under the FD&C Act.
However, FDA understands that a clinical laboratory or other persons may make individual,unsolicited requests to manufacturers for LOINC codes for specific uncleared or unapproved indications for use. In that event, where the manufacturer’s response provides the appropriate LOINC coding for the specific circumstance named in the request or identifies the need for a new LOINC code to address the clinical use referenced in the request, FDA does not intend to consider that response as evidence of the firm’s intent that the product be used for unapproved or uncleared uses.This guidance does not alter the requirements for when IVD tests are required to submit a new premarket notification submission (510(k)) or new Premarket Approval Application (PMA). Additionally, this guidance does not affect requirements applicable to clinical laboratories under other statutes or regulations currently in place.
