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 mass spectrometry community to improve the validation and regulatory review of these devices.
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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 mass spectrometry community to improve the validation and regulatory review of these devices.
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A comprehensive, source-grounded extraction of the reusable knowledge in an episode.
Reusable atomic knowledge units extracted from the episode.
A comprehensive extraction focused on health practices, protocols, claims, and safety caveats.
A comprehensive extraction focused on opportunities, strategy, markets, and company building.
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