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GUIDANCE DOCUMENT

Recommendations for the Submission of LOINC® Codes in Regulatory Applications to the U.S. Food and Drug Administration Guidance for Industry November 2017

Download the Final Guidance Document
Final Level 1 Guidance
Docket Number:
FDA-2017-D-6982
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research

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.

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You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

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Dockets Management
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5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2017-D-6982.

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