Laboratory-Developed Tests: A Legislative and Regulatory Review.
BACKGROUND: Twenty-five years ago, the Food and Drug Administration (FDA) asserted in a draft document that "home brew" tests--now commonly referred to as laboratory-developed tests (LDTs)--are subject to the same regulatory oversight as other in vitro diagnostics (IVDs)4. In 2010, the FDA began wor...
| Publicado en: | Clinical Chemistry Vol. 63; no. 10; pp. 1575 - 1585 |
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| Autores principales: | , , , , |
| Formato: | Journal Article |
| Publicado: |
Oxford University Press / USA
2017
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| Acceso en línea: | Ver este registro en EBSCOhost |