FDA Official Offers Agency's Take on Protein IVDMIA Mock 510(k) Submissions | GenomeWeb

By Adam Bonislawski

As the US Food & Drug Administration refines its policies regarding in vitro diagnostic multivariate index assays, attention to assay reproducibility issues and selection of appropriate intended use populations will be key to the success of proteomics-based tests, FDA staff fellow Joshua Levin suggested at a talk this week discussing the agency's 2009 review of two mock 510(k) submissions for protein IVDMIAs.

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