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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Detalles Bibliográficos
Autor principal: Genzen, Jonathan R
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Oxford University Press 2019
Materias:
Review Article
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6610067/
https://www.ncbi.nlm.nih.gov/pubmed/31242284
http://dx.doi.org/10.1093/ajcp/aqz096

Internet

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6610067/
https://www.ncbi.nlm.nih.gov/pubmed/31242284
http://dx.doi.org/10.1093/ajcp/aqz096

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