Recommendations for the Submission of LOINC® Codes in Regulatory Applications to the U.S. Food and Drug Administration: Guidance for Industry

Issue Date: November 1, 2017
Issued by: Center for Drug Evaluation and Research
Topic(s):
Status: Final

Recommendations for the Submission of LOINC® Codes in Regulatory Applications to the U.S. Food and Drug Administration: Guidance for Industry

Regulated clinical research is carried out and supported across multiple sectors including academic medical centers, biopharmaceutical companies, biotechnology companies, clinical research organizations, federal agencies, information technology vendors and others. The FDA will soon begin requiring the inclusion of a medical laboratory and observation terminology coding system, Logical Observation Identifiers Names and Codes (LOINC®). While this requirement will help align semantics between healthcare and regulated clinical research, readiness for this requirement and understanding of LOINC can vary dramatically across these sectors.

Download the Guidance Document