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Regulation of Laboratory-Developed Tests: A Clinical Laboratory Perspective

OBJECTIVES: To provide a clinical laboratory perspective on the Verifying Accurate Leading-edge IVCT Development Act (VALID) discussion draft. This potential legislative effort, if enacted, would overhaul the regulatory oversight of in vitro diagnostics (IVDs) in the United States and create a singl...

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Dades bibliogràfiques
Publicat a:Am J Clin Pathol
Autor principal: Genzen, Jonathan R
Format: Artigo
Idioma:Inglês
Publicat: Oxford University Press 2019
Matèries:
Accés en línia:https://ncbi.nlm.nih.gov/pmc/articles/PMC6610067/
https://ncbi.nlm.nih.gov/pubmed/31242284
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1093/ajcp/aqz096
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