US Food and Drug Administration Perspectives on Clinical Mass Spectrometry.


Mass spectrometry-based in vitro diagnostic devices that measure proteins and peptides are underutilized in clinical practice, and none has been cleared or approved by the Food and Drug Administration (FDA) for marketing or for use in clinical trials. One way to increase their utilization is through enhanced interactions between the FDA and the clinical… (More)
DOI: 10.1373/clinchem.2015.244731


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