FDA's Final Rule on Laboratory Developed Tests

Clin Chem. 2024 Sep 3;70(9):1192-1194. doi: 10.1093/clinchem/hvae104.

Authors

Xander M R van Wijk¹, Stephen R Master^{2

3}, Jonathan R Genzen^{4

5}

Affiliations

¹ van Wijk Consulting LLC, Houston, TX, United States.
² Department of Pathology and Laboratory Medicine, Children's Hospital of Philadelphia, Philadelphia, PA, United States.
³ Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, United States.
⁴ Department of Pathology, University of Utah Health, Salt Lake City, UT, United States.
⁵ Medical Directorship, ARUP Laboratories, Salt Lake City, UT, United States.

PMID: 39222938
DOI: 10.1093/clinchem/hvae104

No abstract available

MeSH terms

Clinical Laboratory Techniques / standards
Humans
United States
United States Food and Drug Administration*