The long and winding regulatory road for laboratory-developed tests.

Abstract

"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… (More)
DOI: 10.1309/AJCP6OAULC3CMFEJ

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Cite this paper

@article{Weiss2012TheLA, title={The long and winding regulatory road for laboratory-developed tests.}, author={Ronald L. Weiss}, journal={American journal of clinical pathology}, year={2012}, volume={138 1}, pages={20-6} }