The FDA's proposed rule on laboratory-developed tests: what happens next?

Lab Med. 2024 Mar 7;55(2):109-110. doi: 10.1093/labmed/lmae001.

Authors

Jonathan R Genzen^{1

2}, Karen A Moser^{1

2}

Affiliations

¹ Department of Pathology, University of Utah Health, Salt Lake City, UT, US.
² ARUP Laboratories, Salt Lake City, UT, US.

PMID: 38373253
DOI: 10.1093/labmed/lmae001

No abstract available

Keywords: Clinical Laboratory Improvement Amendments; Food and Drug Administration; federal regulations; laboratory-developed tests.

Publication types

Editorial