The long and winding regulatory road for laboratory-developed tests.
"High complexity" clinical laboratories are approved under the Clinical Laboratory Improvement Amendments to develop, validate, and offer a laboratory-developed test (LDT) for clinical use. The Food and Drug Administration considers LDTs to be medical devices under their regulatory jurisdiction, and that at least certain LDTs should be subject to greater regulatory scrutiny. This review describes the current regulatory framework for LDTs and suggests ways in which to appropriately enhance this framework.
Dept of Pathology, University of Utah School of Medicine, ARUP Laboratories, 500 Chipeta Way, Salt Lake City, UT 84108, USA.
Ronald L
RL
Weiss
D019411:Clinical Laboratory Techniques; D006801:Humans; D013677:Medical Laboratory Science / Q000331:legislation & jurisprudence*; D010336:Pathology / Q000331:legislation & jurisprudence; D011785:Quality Assurance, Health Care / Q000331:legislation & jurisprudence*; D014481:United States; D014486:United States Food and Drug Administration